VIDAS® 3 412590Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03573026380175), received between Sep 23, 2019 and May 12, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Pumping Problem” (17 reports).

4 other recalls cover devices cleared under the same FDA submission (K141133); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Pumping Problem

  INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2026, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF A PUMP ISSUE THAT LED TO FALSE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER (B)(6)). THE CUSTOMER NOTICED THAT THERE WAS AN ISSUE WITH THE CALIBRATION MADE WITH THE TOXO IGG PARAMETER, WHICH SHOWED SYSTEMATIC DISCREPANCIES IN POSITION A2 WITH RELATIVE FLUORESCENCE VALUE TWO TIMES LOWER COMPARED TO OTHER POSITIONS. THE FIRST INVALID CALIBRATION OCCURRED AROUND (B)(6) 2026. A RETROSPECTIVE ANALYSIS OF CALIBRATION AND PATIENT REPORTS SHOWN THAT UP TO 16 PATIENTS MAY HAVE BEEN AFFECTED ACROSS ASSAYS (EBNA, CORS, VCAM, CMVM, CMVG, LYM, LH AND TXG), ALL LAUNCHED-ON POSITION A2. HOWEVER, AT THE TIME OF THE ASSESSMENT, NO ADDITIONAL TESTING HAD BEEN PERFORMED BY THE CUSTOMER ON THESE PATIENT SAMPLES. AS A RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150581 ↗
• MalfunctionAug 8, 2025Failure to Sense; Failure to Sense

  INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER (B)(6)). THE CUSTOMER REALIZED A LACK OF REPEATABILITY BECAUSE THE VALUES WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION WHILE TESTING WITH VIDAS BRHAMS PCT. SUBSEQUENTLY, THIS LACK OF REPEATABILITY WAS ONLY FOUND IN SECTION A BECAUSE, WHEN REPEATING PATIENTS USING THE OTHER SECTIONS, THE VALUES WERE CONSISTENT WITH THE PATIENTS' CLINICAL SITUATION. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS (FROM (B)(6) 2025 TO TODAY) AND FOUND THAT THERE WERE NO OTHER REPEATABILITY ANOMALIES WITH OTHER PATIENTS AND THAT THIS ISSUE HAD OCCURRED IN THE LAST 5 PATIENTS. THE RESULTS FOR THE LAST FIVE PATIENTS ARE THE FOLLOWING: PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751149 ↗
• MalfunctionAug 8, 2025Failure to Sense; Failure to Sense

  INTENDED USE **************** THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION ************ ON 04-AUG-2025, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER (B)(6). THE CUSTOMER REALIZED A LACK OF REPEATABILITY BECAUSE THE VALUES WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION WHILE TESTING WITH VIDAS BRHAMS PCT. SUBSEQUENTLY, THIS LACK OF REPEATABILITY WAS ONLY FOUND IN SECTION A BECAUSE, WHEN REPEATING PATIENTS USING THE OTHER SECTIONS, THE VALUES WERE CONSISTENT WITH THE PATIENTS' CLINICAL SITUATION. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS (FROM 01-AUG-2025 TO TODAY) AND FOUND THAT THERE WERE NO OTHER REPEATABILITY ANOMALIES WITH OTHER PATIENTS AND THAT THIS ISSUE HAD OCCURRED IN THE LAST 5 PATIENTS. THE RESULTS FOR THE LAST FIVE PATIENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751121 ↗
• MalfunctionAug 8, 2025Failure to Sense; Failure to Sense

  INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER (B)(6). THE CUSTOMER REALIZED A LACK OF REPEATABILITY BECAUSE THE VALUES WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION WHILE TESTING WITH VIDAS BRHAMS PCT. SUBSEQUENTLY, THIS LACK OF REPEATABILITY WAS ONLY FOUND IN SECTION A BECAUSE, WHEN REPEATING PATIENTS USING THE OTHER SECTIONS, THE VALUES WERE CONSISTENT WITH THE PATIENTS' CLINICAL SITUATION. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS (FROM (B)(6) 2025 TO TODAY) AND FOUND THAT THERE WERE NO OTHER REPEATABILITY ANOMALIES WITH OTHER PATIENTS AND THAT THIS ISSUE HAD OCCURRED IN THE LAST 5 PATIENTS. THE RESULTS FOR THE LAST FIVE PATIENTS ARE THE FOLLOWING: PATIENT 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751109 ↗
• MalfunctionAug 8, 2025Failure to Sense; Failure to Sense

  INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER: (B)(6). THE CUSTOMER REALIZED A LACK OF REPEATABILITY BECAUSE THE VALUES WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION WHILE TESTING WITH VIDAS BRHAMS PCT. SUBSEQUENTLY, THIS LACK OF REPEATABILITY WAS ONLY FOUND IN SECTION A BECAUSE, WHEN REPEATING PATIENTS USING THE OTHER SECTIONS, THE VALUES WERE CONSISTENT WITH THE PATIENTS' CLINICAL SITUATION. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS (FROM ON (B)(6) 2025 TO TODAY) AND FOUND THAT THERE WERE NO OTHER REPEATABILITY ANOMALIES WITH OTHER PATIENTS AND THAT THIS ISSUE HAD OCCURRED IN THE LAST 5 PATIENTS. THE RESULTS FOR THE LAST FIVE PATIENTS ARE THE FOLLOWING: PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751085 ↗
• MalfunctionAug 8, 2025Failure to Sense; Failure to Sense

  INTENDED USE THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION ON (B)(6) 2025, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE RESULTS WHEN USING VIDAS 3 - (REF. 412590, SERIAL NUMBER (B)(6). THE CUSTOMER REALIZED A LACK OF REPEATABILITY BECAUSE THE VALUES WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION WHILE TESTING WITH VIDAS BRHAMS PCT. SUBSEQUENTLY, THIS LACK OF REPEATABILITY WAS ONLY FOUND IN SECTION A BECAUSE, WHEN REPEATING PATIENTS USING THE OTHER SECTIONS, THE VALUES WERE CONSISTENT WITH THE PATIENTS' CLINICAL SITUATION. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS (FROM (B)(6) 2025 TO TODAY) AND FOUND THAT THERE WERE NO OTHER REPEATABILITY ANOMALIES WITH OTHER PATIENTS AND THAT THIS ISSUE HAD OCCURRED IN THE LAST 5 PATIENTS. THE RESULTS FOR THE LAST FIVE PATIENTS ARE THE FOLLOWING: PATIENT 1:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751069 ↗
• MalfunctionJun 11, 2025Failure to Sense; Pumping Problem; Failure to Sense; Pumping Problem

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 15-MAY-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A PUMP ISSUE IN POSITION C1 WHEN USING VIDAS 3 (REF. 412590, SERIAL NUMBER: (B)(6)) LEADING TO FALSE RESULTS WHEN TESTING PATIENT SAMPLES. THE CUSTOMER TESTED CONTROL MATERIAL THAT GAVE INCORRECT RESULTS FOR AN ASSAY (ASSAY NOT SPECIFIED) IN POSITION C1 OF VIDAS 3 INSTRUMENT. RESULTS SHOULD BE THE 80S AND THEY WERE IN THE 20S IN POSITION C1 MULTIPLE TIMES. HOWEVER, THE RESULTS WERE IN THE 80S IN THE OTHER POSITIONS OF VIDAS 3 INSTRUMENT. THE CUSTOMER PERFORMED THEN A RETROSPECTIVE ANALYSIS OF PATIENT SAMPLES TESTED IN C1 POSITION BETWEEN THE LAST TIME THE QC PASSED IN SLOT C1 TO THE TIME IT FAILED AND HIGHLIGHTED A CHANGE OF INTERPRETATION FOR 5 SAMPLES. FOR 4 OUT OF 5: NEGATIVE INITIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187007 ↗
• MalfunctionJun 11, 2025Failure to Sense; Pumping Problem; Failure to Sense; Pumping Problem

  PRODUCT DESCRIPTION THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION ON (B)(6) 2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A PUMP ISSUE IN POSITION C1 WHEN USING VIDAS 3 (REF. (B)(4), SERIAL NUMBER: (B)(6)) LEADING TO FALSE RESULTS WHEN TESTING PATIENT SAMPLES. THE CUSTOMER TESTED CONTROL MATERIAL THAT GAVE INCORRECT RESULTS FOR AN ASSAY (ASSAY NOT SPECIFIED) IN POSITION C1 OF VIDAS 3 INSTRUMENT. RESULTS SHOULD BE THE 80S AND THEY WERE IN THE 20S IN POSITION C1 MULTIPLE TIMES. HOWEVER, THE RESULTS WERE IN THE 80S IN THE OTHER POSITIONS OF VIDAS 3 INSTRUMENT. THE CUSTOMER PERFORMED THEN A RETROSPECTIVE ANALYSIS OF PATIENT SAMPLES TESTED IN C1 POSITION BETWEEN THE LAST TIME THE QC PASSED IN SLOT C1 TO THE TIME IT FAILED AND HIGHLIGHTED A CHANGE OF INTERPRETATION FOR 5 SAMPLES. FOR 4 OUT OF 5: NEGATIVE INITIAL RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186798 ↗
• MalfunctionJun 11, 2025Failure to Sense; Pumping Problem; Failure to Sense; Pumping Problem

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 15-MAY-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A PUMP ISSUE IN POSITION C1 WHEN USING VIDAS 3 (REF. 412590, SERIAL NUMBER: (B)(6)) LEADING TO FALSE RESULTS WHEN TESTING PATIENT SAMPLES. THE CUSTOMER TESTED CONTROL MATERIAL THAT GAVE INCORRECT RESULTS FOR AN ASSAY (ASSAY NOT SPECIFIED) IN POSITION C1 OF VIDAS 3 INSTRUMENT. RESULTS SHOULD BE THE 80S AND THEY WERE IN THE 20S IN POSITION C1 MULTIPLE TIMES. HOWEVER, THE RESULTS WERE IN THE 80S IN THE OTHER POSITIONS OF VIDAS 3 INSTRUMENT. THE CUSTOMER PERFORMED THEN A RETROSPECTIVE ANALYSIS OF PATIENT SAMPLES TESTED IN C1 POSITION BETWEEN THE LAST TIME THE QC PASSED IN SLOT C1 TO THE TIME IT FAILED AND HIGHLIGHTED A CHANGE OF INTERPRETATION FOR 5 SAMPLES. FOR 4 OUT OF 5: NEGATIVE INITIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186591 ↗
• MalfunctionJun 11, 2025Failure to Sense; Pumping Problem; Failure to Sense; Pumping Problem

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 15-MAY-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A PUMP ISSUE IN POSITION C1 WHEN USING VIDAS 3 (REF. 412590, SERIAL NUMBER: (B)(6)) LEADING TO FALSE RESULTS WHEN TESTING PATIENT SAMPLES. THE CUSTOMER TESTED CONTROL MATERIAL THAT GAVE INCORRECT RESULTS FOR AN ASSAY (ASSAY NOT SPECIFIED) IN POSITION C1 OF VIDAS 3 INSTRUMENT. RESULTS SHOULD BE THE 80S AND THEY WERE IN THE 20S IN POSITION C1 MULTIPLE TIMES. HOWEVER, THE RESULTS WERE IN THE 80S IN THE OTHER POSITIONS OF VIDAS 3 INSTRUMENT. THE CUSTOMER PERFORMED THEN A RETROSPECTIVE ANALYSIS OF PATIENT SAMPLES TESTED IN C1 POSITION BETWEEN THE LAST TIME THE QC PASSED IN SLOT C1 TO THE TIME IT FAILED AND HIGHLIGHTED A CHANGE OF INTERPRETATION FOR 5 SAMPLES. FOR 4 OUT OF 5: NEGATIVE INITIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186562 ↗
• MalfunctionJun 11, 2025Failure to Sense; Pumping Problem; Failure to Sense; Pumping Problem

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 15-MAY-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A PUMP ISSUE IN POSITION C1 WHEN USING VIDAS 3 (REF. (B)(4), SERIAL NUMBER: (B)(6)) LEADING TO FALSE RESULTS WHEN TESTING PATIENT SAMPLES. THE CUSTOMER TESTED CONTROL MATERIAL THAT GAVE INCORRECT RESULTS FOR AN ASSAY (ASSAY NOT SPECIFIED) IN POSITION C1 OF VIDAS 3 INSTRUMENT. RESULTS SHOULD BE THE 80S AND THEY WERE IN THE 20S IN POSITION C1 MULTIPLE TIMES. HOWEVER, THE RESULTS WERE IN THE 80S IN THE OTHER POSITIONS OF VIDAS 3 INSTRUMENT. THE CUSTOMER PERFORMED THEN A RETROSPECTIVE ANALYSIS OF PATIENT SAMPLES TESTED IN C1 POSITION BETWEEN THE LAST TIME THE QC PASSED IN SLOT C1 TO THE TIME IT FAILED AND HIGHLIGHTED A CHANGE OF INTERPRETATION FOR 5 SAMPLES. FOR 4 OUT OF 5: NEGATIVE INITIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186540 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION. THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION. ON (B)(6) 2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. (B)(4), SERIAL NO. (B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: - HAVT: 15 PATIENTS. - GDH: 19 PATIENTS. - CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146300 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 27-MAY-2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL NO.(B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: HAVT: 15 PATIENTS, GDH: 19 PATIENTS, CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIVE TO NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146222 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. (B)(4), SERIAL NO. (B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: - HAVT: 15 PATIENTS. - GDH: 19 PATIENTS. - CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146203 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. (B)(4), SERIAL NO. (B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: - HAVT: 15 PATIENTS. - GDH: 19 PATIENTS. - CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146202 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION : THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 27-MAY-2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL NO. (B)(6). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: - HAVT: 15 PATIENTS - GDH: 19 PATIENTS - CDAB: 4 PATIENTS THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146182 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON 27-MAY-2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL NO. (B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: HAVT: 15 PATIENTS, GDH: 19 PATIENTS, CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIVE TO N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146177 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION. THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION. ON (B)(6) 2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. (B)(4), SERIAL NO. (B)(6)). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: - HAVT: 15 PATIENTS. - GDH: 19 PATIENTS. - CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146160 ↗
• MalfunctionJun 4, 2025Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POSSIBLE ERRONEOUS PATIENT RESULTS TESTED IN POSITION B1 OF THEIR VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL NO. (B)(6). THE CUSTOMER NOTICED OVERESTIMATED RESULTS ON POSITION B1 OF THEIR VIDAS. A FIELD SERVICE ENGINEER (FSE) INTERVENTION HAS BEEN PLANNED TO SOLVE THE ISSUE. THE CUSTOMER PERFORMED AN IMPACT STUDY FOR POTENTIAL FALSE RESULTS THAT HAVE BEEN PERFORMED AND COMMUNICATED TO THE CLINICIANS. THE CUSTOMER IDENTIFIED SAMPLES TESTED WITH HAVT, GDH, AND CDAB KITS. THE SAMPLES PERFORMED DURING THIS PERIOD ON THIS B1 POSITION: HAVT: 15 PATIENTS, GDH: 19 PATIENTS, CDAB: 4 PATIENTS. THE CUSTOMER ALREADY RETESTED ALL PATIENTS FOR HAVT AND EIGHT (8) PATIENT SAMPLES HAD AN INTERPRETATION CHANGE FROM POSITIVE TO NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146149 ↗
• InjuryMay 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS WITH PATIENT SAMPLES WHEN USING THEIR VIDAS 3 INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6)). A FSE (FIELD SERVICE ENGINEER) WAS PREVIOUSLY DISPATCHED TO THE CUSTOMER'S SITE TWICE IN (B)(6) 2025 TO ASSESS THE INSTRUMENT AFTER THE CUSTOMER REPORTED HAVING ISSUES WITH FALSE POSITIVE RESULTS FOR EXTERNAL QC SAMPLES. SECTION B SPR BLOCK AND SECTION PCB WERE REPLACED, BUT ERRORS PERSISTED. A PUMP FAILURE WAS SUSPECTED. AFTER PUMP REPLACEMENT, THE INSTRUMENT WAS FUNCTIONING AS INTENDED. FOLLOWING THE INSTRUMENT INTERVENTIONS, THE CUSTOMER REVIEWED ALL THEIR RESULTS TESTED FROM POSITION B TO SEE IF THERE WAS ANY PATIENT SAMPLES IMPACTED. THE CUSTOMER REVIEWED PATIENT RE

  Patient problems: Insufficient Information

  MAUDE report 22023216 ↗
• InjuryMay 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER FROM THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS WITH PATIENT SAMPLES WHEN USING THEIR VIDAS 3 INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6)). A FSE (FIELD SERVICE ENGINEER) WAS PREVIOUSLY DISPATCHED TO THE CUSTOMER'S SITE TWICE IN (B)(6) 2025 TO ASSESS THE INSTRUMENT AFTER THE CUSTOMER REPORTED HAVING ISSUES WITH FALSE POSITIVE RESULTS FOR EXTERNAL QC SAMPLES. SECTION B SPR BLOCK AND SECTION PCB WERE REPLACED, BUT ERRORS PERSISTED. A PUMP FAILURE WAS SUSPECTED. AFTER PUMP REPLACEMENT, THE INSTRUMENT WAS FUNCTIONING AS INTENDED. FOLLOWING THE INSTRUMENT INTERVENTIONS, THE CUSTOMER REVIEWED ALL THEIR RESULTS TESTED FROM POSITION B TO SEE IF THERE WAS ANY PATIENT SAMPLES IMPACTED. THE CUSTOMER REVIEWED PATIENT RE

  Patient problems: Insufficient Information

  MAUDE report 22023122 ↗
• MalfunctionSep 4, 2024Failure to Transmit Record; Failure to Transmit Record

  ON 20-AUG-2024, A CUSTOMER FROM CHINESE TAIPEI NOTIFIED BIOMÉRIEUX OF OBTAINING OVERESTIMATED RESULT WHEN TESTING PATIENT WITH VIDAS® D-DIMER EXCLUSION II (REF. 30455) IN VIDAS 3 INSTRUMENT (REF. 412590, SERIAL NUMBER: (B)(6). THE CUSTOMER ANALYZED PATIENT SAMPLE WITH VIDAS® D-DIMER EXCLUSION II (REF. 30455) IN VIDAS 3 INSTRUMENT (REF. 412590, SERIAL NUMBER: (B)(6), SOFTWARE VERSION: V1.4.0) WITH THE ¿LOAD AND GO¿ MODE AND OBTAINED THE FOLLOWING RESULTS: WHEN THE TEST IS PERFORMED IN THE SAME SECTION WITH VIDAS® NT-PROBNP2 TEST: 480 NG/ML WHEN THE TEST IS PERFORMED WITHOUT ANY OTHER TEST IN THE SECTION: 212 NG/ML ACCORDING TO VIDAS ASSAY COMPATIBILITY INFORMATION, THE VIDAS® D-DIMER EXCLUSION II (REF. 30455) AND VIDAS® NT-PROBNP2 TESTS COULD NOT BE PROCESSED IN THE SAME SECTION BECAUSE THE PROTOCOLS ARE DIFFERENT. AND IN THIS CASE, NO ALARM WAS TRIGGERED BY VIDAS 3 INSTRUMENT (REF. 412590, SERIAL NUMBER: (B)(6), SOFTWARE VERSION: V1.4.0). BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS ASSESSMENT, THERE IS NO DATA AVAILABLE REGARDING A POTENTIAL PATIENT¿S IMPACT OF THIS ISSUE, OR ANY DELAYED OF RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134302 ↗
• MalfunctionJun 20, 2024Break; Break

  PRODUCT DESCRIPTION THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR WHEN USING VIDAS® 3 REFERENCE (B)(4) SERIAL NUMBER (B)(6) . THE CUSTOMER REPORTED THE VIDAS® 3 WAS "FROZEN". BIOMÉRIEUX FSE REPLACED NUMEROUS COMPONENTS UNTIL THE SYSTEM WAS ABLE TO COMMUNICATE WITH ITSELF. REPLACED PIPETTOR, PIPETTOR BOARD, LOADING BAY, LOADING BAY BOARD, SCANNER, SCANNER BOARD, SCANNER CABLE, POWER SUPPLY AND SMB. THE SYSTEM WAS THEN ABLE TO SUCCESSFULLY PASS ALL POST SERVICE TESTS AND CHECKS. AT THE TIME OF THE ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. THE CUSTOMER DID REPORT A PATIENT'S PCT RESULT DELAY OF 5 DAYS DUE TO THE ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576969 ↗
• MalfunctionNov 30, 2023Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION. THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS INTENDED TO BE USED WITH VIDAS® REAGENTS IN CLINICAL LABORATORIES ONLY. THIS DEVICE IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE FOR PROFESSIONAL USE ONLY. ISSUE DESCRIPTION ON 10-NOV-2023, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF POTENTIAL FALSE POSITIVE PATIENT RESULTS WHEN USING COMPARTMENT D OF VIDAS® 3 SYSTEM REFERENCE (B)(4) (SERIAL NUMBER (B)(6). THIS CUSTOMER NOTICED THAT THE RESULTS FOR POSITION D1 WERE NOT IDENTICAL WITH THE OTHER POSITIONS (THIS STARTED WITH THE C2 HIV CONTROL). CUSTOMER RESULTS: C2 HIV : 0.42 (POSITIVE) - 101 RFV - AUTOMATIC - D1. 0.09 (NEGATIVE) - 22 RFV - MANUAL - C1. HIV PATIENT : 0.48 (POSITIVE) - 115 RFV - AUTOMATIC - D1. 0.08 (NEGATIVE) - 21 RFV - AUTOMATIC - A1. PATIENT FOR VCAM : 0.46 (POSITIVE) - 366 RFV - AUTOMATIC - D1. 0.06 (NEGATIVE) - 50 RFV - MANUAL - B1. THE INSTRUMENT LOGS ANALYSIS CONCLUDED THAT THERE WAS NO PROBLEM IDENTIFIED. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235738 ↗
• MalfunctionJul 19, 2023Failure to Calibrate; Failure to Calibrate

  INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STAND-ALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINISTRATORS (APPLICATION CONFIGURATION). VIDAS® BRAHMS PCT¿ (PCT) IS AN AUTOMATED TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARINATE) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® BRAHMS PCT¿ IS INTENDED FOR USE AS FOLLOWS: TO AID IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. TO AID IN ASSESSING THE CUMULATIVE 28-DAY RISK OF ALL-CAUSE MORTALITY FOR PATIENTS DIAGNOSED WITH SEVERE SEPSIS OR SEPTIC SHOCK IN THE ICU OR WHEN OBTAINED IN THE EMERGENCY DEPARTMENT OR OTHER MEDICAL WARDS PRIOR TO ICU ADMISSION, USING A CHANGE IN PCT LEVEL OVER TIME. TO AID IN DECISION MAKING ON ANTIBIOTIC THERAPY FOR PATIENTS WITH SUSPECTED OR CONFIRMED LOWER RESPIRATORY TRACT INFECTIONS (LRTI) ¿ DEFINED AS COMMUNITY-ACQUIRED PNEUMONIA (CAP), ACUTE BRONCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141133. One submission often covers many models, so check the product and lot details in each record.

• Z-0797-2023 · Nov 9, 2022 · Open, Classified
  VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
• Z-0864-2023 · Nov 9, 2022 · Open, Classified
  VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
• Z-0427-2022 · Sep 22, 2021 · Open, Classified
  VIDAS DEX@, Dimer Exclusion II, REF 30455-01
• Z-0928-2020 · Oct 22, 2019 · Terminated
  BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation