mini VIDAS® 99737Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 03573026140441), received between Feb 13, 2017 and Jun 10, 2025 — classified as 3 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (42 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K923579); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 4, 2018Terminated

   Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a decrease of pipetted volume.

   Z-2428-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE MINI VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE MINI VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. QCV-QUALITY CONTROL VIDAS 60T (REF. (B)(4): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS® AND MINI VIDAS® INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. VIDAS BRAHMS PROCALCITONIN 60T (REF. (B)(4)): VIDAS® BRAHMS PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® BRAHMS PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® BRAHMS PCT¿ ALSO AIDS IN D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179042 ↗
• MalfunctionJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION ************ THE MINI VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE MINI VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. QCV-QUALITY CONTROL VIDAS 60T (REF. 30706): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS® AND MINI VIDAS® INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. VIDAS BRAHMS PROCALCITONIN 60T (REF. 30450-01): VIDAS® B·R·A·H·M·S PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B¿R¿A¿H¿M¿S PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178983 ↗
• MalfunctionJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE MINI VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE MINI VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. QCV-QUALITY CONTROL VIDAS 60T (REF. (B)(4)): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS® AND MINI VIDAS® INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. VIDAS BRAHMS PROCALCITONIN 60T (REF. (B)(4)): VIDAS® BRAHMS PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® BRAHMS PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® BRAHMS PCT¿ ALSO AIDS IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178971 ↗
• MalfunctionJun 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PRODUCT DESCRIPTION: THE MINI VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE MINI VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. QCV-QUALITY CONTROL VIDAS 60T (REF. (B)(4)): AUTOMATED TEST FOR USE ON THE VIDAS® SYSTEM TO DETECT ABNORMAL OPERATION OF THE VIDAS® AND MINI VIDAS® INSTRUMENT PIPETTE MECHANISMS AND OPTICAL SYSTEMS. VIDAS BRAHMS PROCALCITONIN 60T (REF. (B)(4)): VIDAS® B·R·A·H·M·S PCT¿ IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE DETERMINATION OF HUMAN PROCALCITONIN IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME-LINKED FLUORESCENT ASSAY) TECHNIQUE. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B¿R¿A¿H¿M¿S PCT¿ AIDS IN THE RISK ASSESSMENT OF CRITICALLY ILL PATIENTS ON THEIR FIRST DAY OF ICU ADMISSION, FOR PROGRESSION TO SEVERE SEPSIS AND SEPTIC SHOCK. USED IN CONJUNCTION WITH OTHER LABORATORY FINDINGS AND CLINICAL ASSESSMENTS, VIDAS® B·R·A·H·M·S PCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178965 ↗
• MalfunctionDec 3, 2024Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  ON 21-NOV-2024, A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF A SOFTWARE ISSUE LEADING TO POTENTIAL FALSE RESULTS WHEN USING MINI VIDAS® BLUE 110 / 220 V (REF. 99737, SERIAL NUMBER: (B)(6). THE CUSTOMER REPORTED THAT WHEN TESTING VIDAS® FPSA (REF. 30440, LOT NUMBER: UNKNOWN) AND VIDAS® TESTOSTERONE II (REF. 414320, LOT NUMBER: UNKNOWN) ON MINI VIDAS® BLUE 110 / 220 V REFERENCE: 99737 (SERIAL NUMBER: (B)(6), THE RESULTS OBTAINED CONCERNED VIDAS®TPSA (REF. 30428) PARAMETER AND NOT FPSA OR TESTOSTERONE II PARAMETERS WHEREAS FPSA OR TESII STRIP / SPR WERE INSIDE. THE CUSTOMER SWITCHED OFF THE MINI VIDAS ® BLUE 110 / 220 V (REF. 99737) AND STARTED A NEW RUN, BUT THE ERROR REOCCURRED. ACCORDING TO THE USER MANUAL, THE MINI VIDAS®BLUE READS THE BAR CODE ON THE LABEL OF EACH REAGENT STRIP AND PERFORMS AN OPTICAL CHECK OF THE SUBSTRATE. IF ONE OF THESE CHECKS FAILS, A START ERROR MESSAGE WILL APPEAR. START ERRORS CAUSE THE MINI VIDAS®BLUE TO STOP THE RUN IN THE SECTION CONTAINING THE ERROR. BUT THE CUSTOMER STATES THAT THE INSTRUMENT DID NOT STOP AND RAN INSTEAD A DIFFERENT PROTOCOL (VIDAS®TPSA). THE CUSTOMER DID NOT USE ¿LOAD AND GO¿ MODE BUT RAN THE ASSAY VIA THE ¿STATUS¿ MENU. TO BE NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20837766 ↗
• MalfunctionJul 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 25-JUN-2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING QUALITY CONTROL VIDAS TEST FAILURE WHEN USING MINI VIDAS® BLUE 110 / 220 V (REF. 99737 SERIAL NUMBER (B)(6)). THE ISSUE OCCURRED ON (B)(6) 2024 ON SIDE B, SECTION B1. THE LAST VALID QUALITY CONTROL VIDAS TEST WAS DONE ON (B)(6) 2024. BETWEEN THESE TWO DATES, THREE TESTS WERE PERFORMED WITH VIADS® BRAMHS PROCALCITONIN (REF. 30450-01). QUALITY CONTROL VIDAS TEST FAILURE IS NOT A MALFUNCTION; HOWEVER, IT COULD BE ASSOCIATED WITH INCORRECT RESULTS (PRIOR TO THE QUALITY CONTROL VIDAS TEST FAILURE). IN THE CASE OF A QUALITY CONTROL VIDAS TEST FAILURE, BIOMÉRIEUX REQUESTS CUSTOMERS CONDUCT A RETROSPECTIVE ANALYSIS FROM THE LAST PASSED QUALITY CONTROL VIDAS TEST UNTIL THE PRESENT QUALITY CONTROL VIDAS TEST FAILURE. THE RETROSPECTIVE ANALYSIS SHOWED THAT AMONG THE THREE SAMPLES ANALYZED BEFORE THE ISSUE, ONE MADE ON (B)(6)2024 GAVE A POSITIVE RESULT (2.75 NG/ML), WHICH MEANS ACCORDING THE INSTRUCTION FOR USE OF VIDAS BRAMHS PCT: SUGGESTIVE OF PRESENCE OF BACTERIAL INFECTION. ANTIBIOTIC THERAPY STRONGLY RECOMMENDED. THE RETEST MADE ON (B)(6) 2024, GAVE A NEGATIVE RESULT (0.09 NG/M, BELOW THE CUTOFF OF 0.10 NG/ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690121 ↗
• MalfunctionApr 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 15-APR-2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING QUALITY CONTROL VIDAS (QCV) TEST FAILURE WHEN USING MINI VIDAS BLUE 110 / 220 V (REF. 99737 SERIAL NUMBER (B)(6)). THE QCV ERROR APPEARED ON 15-APR-2024. THE POSITION A2 FAILED TWO TIMES THE QCV TEST. THE SECTION A WAS THEN DISABLED. THE LAST CONFORM QUALITY CONTROL VIDAS (QCV) TEST WAS MADE ON 08-APR-2024. BETWEEN THE 08-APR-2024 AND 15-APR-2024, THIRTEEN SAMPLES WERE CONCERNED AND WERE THEN RE-TESTED AFTER THE QCV ISSUE APPEARED. FROM THE THIRTEEN SAMPLES, ONE SAMPLE ANALYZED ON 15-APR-2024 GAVE A RESULT OF 0.55 NG/ML FOR VIDAS® BRAHMS PCT BEFORE THE ISSUE AND < 0.05 NG/ML FOR THE RE-TEST MADE THE SAME DAY. QCV DONE ON 18-APR-2024 WAS VALID. THE CUSTOMER USE TO PERFORM THE QCV TEST ON A WEEKLY BASIS AS MANDATORY. THE CUSTOMER CONFIRMED THAT THE DISCREPANT RESULT DID NOT LEAD TO ANY ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217075 ↗
• MalfunctionMar 27, 2024Defective Component; Defective Component

  ON 02-MAR-2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING MULTIPLE ERRORS ON MINI VIDAS BLUE 110 / 220 V (REF. (B)(4) SERIAL NUMBER (B)(6). ERRORS 2059 (DOOR ERROR) AND 2075 (CONFIGURATION NOT FOUND) INDICATING A VIC BOARD ERROR WERE DISPLAYED ON MINI VIDAS AND PREVENTED CUSTOMER FROM RUNNING THE SAMPLES AS HE DOES NOT HAVE A BACK-UP TESTING METHOD. AS A CONSEQUENCE, THERE WERE DELAYED PATIENT RESULTS OF MORE THAN 6 HOURS FOR FIVE (5) PATIENT SAMPLES WHICH WERE WAITING ON VIDAS PCT TESTING. THE FIVE (5) PATIENT SAMPLES HAD TO BE HELD FOR TWO (2) DAYS WHILE THE INSTRUMENT WAS NOT OPERATIONAL. MEANWHILE, PHYSICIANS STOPPED ORDERING PCT TESTS. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FSE CHANGED THE VIC BOARD AND RELOADED SOFTWARE PER PROCEDURE. FOLLOWING THIS, IT WAS REPORTED THAT THE INSTRUMENT SEEMED TO WORK AGAIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986918 ↗
• MalfunctionMar 27, 2024Defective Component; Defective Component

  ON 02-MAR-2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING MULTIPLE ERRORS ON MINI VIDAS BLUE 110 / 220 V ((B)(4). (B)(6)). ERRORS 2059 (DOOR ERROR) AND 2075 (CONFIGURATION NOT FOUND) INDICATING A VIC BOARD ERROR WERE DISPLAYED ON MINI VIDAS AND PREVENTED CUSTOMER FROM RUNNING THE SAMPLES AS HE DOES NOT HAVE A BACK-UP TESTING METHOD. AS A CONSEQUENCE, THERE WERE DELAYED PATIENT RESULTS OF MORE THAN 6 HOURS FOR FIVE (5) PATIENT SAMPLES WHICH WERE WAITING ON VIDAS PCT TESTING. THE FIVE (5) PATIENT SAMPLES HAD TO BE HELD FOR TWO (2) DAYS WHILE THE INSTRUMENT WAS NOT OPERATIONAL. MEANWHILE, PHYSICIANS STOPPED ORDERING PCT TESTS. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FSE CHANGED THE VIC BOARD AND RELOADED SOFTWARE PER PROCEDURE. FOLLOWING THIS, IT WAS REPORTED THAT THE INSTRUMENT SEEMED TO WORK AGAIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986907 ↗
• MalfunctionMar 27, 2024Defective Component; Defective Component

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING MULTIPLE ERRORS ON MINI VIDAS BLUE 110 / 220 V (REF. (B)(4) SERIAL NUMBER (B(6) . ERRORS 2059 (DOOR ERROR) AND 2075 (CONFIGURATION NOT FOUND) INDICATING A VIC BOARD ERROR WERE DISPLAYED ON MINI VIDAS AND PREVENTED CUSTOMER FROM RUNNING THE SAMPLES AS HE DOES NOT HAVE A BACK-UP TESTING METHOD. AS A CONSEQUENCE, THERE WERE DELAYED PATIENT RESULTS OF MORE THAN 6 HOURS FOR FIVE (5) PATIENT SAMPLES WHICH WERE WAITING ON VIDAS PCT TESTING. THE FIVE (5) PATIENT SAMPLES HAD TO BE HELD FOR TWO (2) DAYS WHILE THE INSTRUMENT WAS NOT OPERATIONAL. MEANWHILE, PHYSICIANS STOPPED ORDERING PCT TESTS. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FSE CHANGED THE VIC BOARD AND RELOADED SOFTWARE PER PROCEDURE. FOLLOWING THIS, IT WAS REPORTED THAT THE INSTRUMENT SEEMED TO WORK AGAIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986848 ↗
• MalfunctionMar 27, 2024Defective Component; Defective Component

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING MULTIPLE ERRORS ON MINI VIDAS BLUE 110 / 220 V (REF. (B)(4) SERIAL NUMBER (B)(6). ERRORS 2059 (DOOR ERROR) AND 2075 (CONFIGURATION NOT FOUND) INDICATING A VIC BOARD ERROR WERE DISPLAYED ON MINI VIDAS AND PREVENTED CUSTOMER FROM RUNNING THE SAMPLES AS HE DOES NOT HAVE A BACK-UP TESTING METHOD. AS A CONSEQUENCE, THERE WERE DELAYED PATIENT RESULTS OF MORE THAN 6 HOURS FOR FIVE (5) PATIENT SAMPLES WHICH WERE WAITING ON VIDAS PCT TESTING. THE FIVE (5) PATIENT SAMPLES HAD TO BE HELD FOR TWO (2) DAYS WHILE THE INSTRUMENT WAS NOT OPERATIONAL. MEANWHILE, PHYSICIANS STOPPED ORDERING PCT TESTS. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FSE CHANGED THE VIC BOARD AND RELOADED SOFTWARE PER PROCEDURE. FOLLOWING THIS, IT WAS REPORTED THAT THE INSTRUMENT SEEMED TO WORK AGAIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986832 ↗
• MalfunctionMar 27, 2024Defective Component; Defective Component

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING MULTIPLE ERRORS ON MINI VIDAS BLUE 110 / 220 V (REF. 99737 SERIAL NUMBER (B)(6). ER RORS 2059 (DOOR ERROR) AND 2075 (CONFIGURATION NOT FOUND) INDICATING A VIC BOARD ERROR WERE DISPLAYED ON MINI VIDAS AND PREVENTED CUSTOMER FROM RUNNING THE SAMPLES AS HE DOES NOT HAVE A BACK-UP TESTING METHOD. AS A CONSEQUENCE, THERE WERE DELAYED PATIENT RESULTS OF MORE THAN 6 HOURS FOR FIVE (5) PATIENT SAMPLES WHICH WERE WAITING ON VIDAS PCT TESTING. THE FIVE (5) PATIENT SAMPLES HAD TO BE HELD FOR TWO (2) DAYS WHILE THE INSTRUMENT WAS NOT OPERATIONAL. MEANWHILE, PHYSICIANS STOPPED ORDERING PCT TESTS. A BIOMERIEUX FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FSE CHANGED THE VIC BOARD AND RELOADED SOFTWARE PER PROCEDURE. FOLLOWING THIS, IT WAS REPORTED THAT THE INSTRUMENT SEEMED TO WORK AGAIN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986817 ↗
• MalfunctionMar 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING QCV FAILURE WHEN USING MINI VIDAS BLUE 110 / 220 V (REF. (B)(4) SERIAL NUMBER (B)(6)). ON 09-FEB-2024, THE CUSTOMER¿S QCV FAILED IN POSITION B4. THEREFORE, SECTION B WAS DISCONNECTED. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS ON ALL SAMPLES RAN ON THE B4 POSITION FROM LAST VALID QCV ((B)(6) 2024) UNTIL QCV FAILURE ((B)(6) 2024): OUT OF 5 TESTED SAMPLES, ONLY ONE SAMPLE HAD A CHANGE IN INTERPRETATION WITH VIDAS BRAHMS PROCALCITONIN 60T (REF. (B)(4), LOT NUMBER UNKNOWN): - INITIAL RESULT: 6.41 NG/ML; - RETEST < 0.05 NG/ML. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867650 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS). (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN. (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 2024: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707483 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS) (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 2024: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707455 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS) (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 2024: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707440 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS) (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 20224: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707430 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS) (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 2024: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707404 ↗
• MalfunctionFeb 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON 18-JAN-2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBSERVING INSTRUMENT ISSUES WHEN TESTING PATIENT SAMPLES WITH MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)). CUSTOMER HISTORY: (B)(6) 2023: CUSTOMER ENCOUNTERED MECHANICAL ERROR 1017 ON SECTION A (NO RISK OF FALSE RESULTS) (B)(6) 2024: ERROR 1017 ON SECTION A AGAIN (B)(6) 2024: FIELD SERVICE ENGINEER (FSE) INTERVENTION WITH PUMP REPLACEMENT AND QCV TESTING. FSE MARKED QCV AS CONFORM WHEN IT WAS NOT. THE CUSTOMER PERFORMS THEIR QCV ON A WEEKLY BASIS AS PER MINI VIDAS USER MANUAL, AND THE LAST VALID QCV PRIOR TO THE REPORTED ISSUE WAS FROM (B)(6) 2024. (B)(6) 2024 THROUGH (B)(6) 2024: CUSTOMER SAW AIR BUBBLES ON SECTION A OF MINI VIDAS. THEREFORE, THEY STOPPED USING SECTION A AND DECIDED TO RERUN ALL SAMPLES RAN ON THIS SECTION. (B)(6) 2024 CUSTOMER PERFORM QCV, AND IT IS CONFORM BUT CLOSE TO THE ACCEPTABLE LIMIT. (B)(6) 2024: A SECOND SET OF SAMPLES WERE RUN WITH BUBBLES NOTED. REPEAT TESTING WAS PERFORMED SAME DAY. (B)(6) 2024: FSE INTERVENTION AGAIN WITH A VALID QCV. RETROSPECTIVE ANALYSIS BETWEEN (B)(6) 2024 WAS REQUESTED. OUT OF EIGHT (8) RETESTED SAMPLES, SIX (6) SAMPLES SHOWED CHANGE IN IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707402 ↗
• MalfunctionOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)) WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ (REF (B)(4), LOT UNKNOWN) ON PATIENT SAMPLES. THE CUSTOMER RAN QCV TWICE AND FAILED ON A6 BOTH TIMES. HE OBTAINED THE FOLLOWING RESULTS: EXPECTED RESULT: TV1 > 5.6. -1ST RUN: TV1 = 1.21. -2ST RUN: TV1 = 1.03. LAST KNOWN GOOD QCV 29AUG2023. LOT # OF TEST KIT QCV 1009875550. EXPIRATION DATE 07FEB2024 . ON (B)(6) 2023, THE CUSTOMER ALSO PERFORMED A RETROSPECTIVE ANALYSIS AND HE RETESTED PATIENT SAMPLES USING VIDAS® B·R·A·H·M·S PCT¿ (LOT UNKNOWN). THE CUSTOMER REPORTED THAT THESE SIX PATIENT SAMPLES WERE THE ONLY ONES RAN DURING THE TIME FRAME OF THEIR ISSUE WITH SECTION A. SAMPLES WERE RERUN IN ANOTHER SECTION AND CORRECT RESULTS WERE OBTAINED AS FOLLOW: PATIENT A: (B)(6) 2023 (INITIAL RESULT): <0.05. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05 (NO IMPACT ON RESULT). PATIENT B: (B)(6) 2023 (INITIAL RESULT): 9.94. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): 0.20. PATIENT C: (B)(6) 2023 (INITIAL RESULT): 0.32. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05. PATIENT D: (B)(6) 2023 (INITIAL RESULT)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914179 ↗
• MalfunctionOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V (REF: (B)(4), SERIAL NUMBER: (B)(6)) WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ (REF: (B)(4), LOT UNKNOWN) ON PATIENT SAMPLES. THE CUSTOMER RAN QCV TWICE AND FAILED ON A6 BOTH TIMES. HE OBTAINED THE FOLLOWING RESULTS: EXPECTED RESULT: TV1 > 5.6. -1ST RUN: TV1 = 1.21. -2ST RUN: TV1 = 1.03. LAST KNOWN GOOD QCV 29AUG2023. LOT # OF TEST KIT QCV 1009875550. EXPIRATION DATE 07FEB2024. ON (B)(6) 2023, THE CUSTOMER ALSO PERFORMED A RETROSPECTIVE ANALYSIS AND HE RETESTED PATIENT SAMPLES USING VIDAS® B·R·A·H·M·S PCT¿ (LOT UNKNOWN). THE CUSTOMER REPORTED THAT THESE SIX PATIENT SAMPLES WERE THE ONLY ONES RAN DURING THE TIME FRAME OF THEIR ISSUE WITH SECTION A. SAMPLES WERE RERUN IN ANOTHER SECTION AND CORRECT RESULTS WERE OBTAINED AS FOLLOW: PATIENT A: (B)(6) 2023 (INITIAL RESULT) : <0.05. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05. (NO IMPACT ON RESULT). PATIENT B: (B)(6) 2023 (INITIAL RESULT) : 9.94. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): 0.20. PATIENT C: (B)(6) 2023 (INITIAL RESULT) : 0.32. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05. PATIENT D: (B)(6) 2023 (INITIAL RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914072 ↗
• MalfunctionOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)) WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ (REF (B)(4), LOT UNKNOWN) ON PATIENT SAMPLES. THE CUSTOMER RAN QCV TWICE AND FAILED ON A6 BOTH TIMES. HE OBTAINED THE FOLLOWING RESULTS: EXPECTED RESULT: TV1 > 5.6. -1ST RUN: TV1 = 1.21. -2ST RUN: TV1 = 1.03. LAST KNOWN GOOD QCV 29AUG2023. LOT # OF TEST KIT QCV 1009875550. EXPIRATION DATE 07FEB2024. ON (B)(6) 2023, THE CUSTOMER ALSO PERFORMED A RETROSPECTIVE ANALYSIS AND HE RETESTED PATIENT SAMPLES USING VIDAS® B·R·A·H·M·S PCT¿ (LOT UNKNOWN). THE CUSTOMER REPORTED THAT THESE SIX PATIENT SAMPLES WERE THE ONLY ONES RAN DURING THE TIME FRAME OF THEIR ISSUE WITH SECTION A. SAMPLES WERE RERUN IN ANOTHER SECTION AND CORRECT RESULTS WERE OBTAINED AS FOLLOW: PATIENT A: (B)(6) 2023 (INITIAL RESULT) : <0.05. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05 (NO IMPACT ON RESULT). PATIENT B: (B)(6) 2023 (INITIAL RESULT): 9.94. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): 0.20. PATIENT C: (B)(6) 2023 (INITIAL RESULT): 0.32. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05. PATIENT D: (B)(6) 2023 (INITIAL RESULT)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913988 ↗
• MalfunctionOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V. REF. 99737, SERIAL NUMBER (B)(6) WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ (REF 30450, LOT UNKNOWN) ON PATIENT SAMPLES. THE CUSTOMER RAN QCV TWICE AND FAILED ON A6 BOTH TIMES. HE OBTAINED THE FOLLOWING RESULTS: EXPECTED RESULT: TV1 > 5.6 -1ST RUN: TV1 = 1.21 -2ST RUN: TV1 = 1.03 LAST KNOWN GOOD QCV (B)(6) 2023 LOT # OF TEST KIT QCV 1009875550 EXPIRATION DATE 07FEB2024 ON (B)(6) 2023, THE CUSTOMER ALSO PERFORMED A RETROSPECTIVE ANALYSIS AND HE RETESTED PATIENT SAMPLES USING VIDAS® B·R·A·H·M·S PCT¿ (LOT UNKNOWN). THE CUSTOMER REPORTED THAT THESE SIX PATIENT SAMPLES WERE THE ONLY ONES RAN DURING THE TIME FRAME OF THEIR ISSUE WITH SECTION A. SAMPLES WERE RERUN IN ANOTHER SECTION AND CORRECT RESULTS WERE OBTAINED AS FOLLOW: PATIENT A: (B)(6) 23 (INITIAL RESULT) : <0.05. 12/SEP/23 (RETESTED ON ANOTHER SECTION): <0.05 (NO IMPACT ON RESULT). PATIENT B: (B)(6) 23 (INITIAL RESULT) : 9.94. (B)(6) 23 (RETESTED ON ANOTHER SECTION): 0.20. PATIENT C: (B)(6) 23 (INITIAL RESULT) : 0.32. (B)(6) 23 (RETESTED ON ANOTHER SECTION): <0.05. PATIENT D: (B)(6) 23 (INITIAL RESULT) : 3.00. (B)(6) 23

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913846 ↗
• MalfunctionOct 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V (REF. (B)(4), SERIAL NUMBER (B)(6)) WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ (REF (B)(4), LOT UNKNOWN) ON PATIENT SAMPLES. THE CUSTOMER RAN QCV TWICE AND FAILED ON A6 BOTH TIMES. HE OBTAINED THE FOLLOWING RESULTS: EXPECTED RESULT: TV1 > 5.6. -1ST RUN: TV1 = 1.21. -2ST RUN: TV1 = 1.03. LAST KNOWN GOOD QCV 29AUG2023. LOT # OF TEST KIT QCV 1009875550. EXPIRATION DATE 07FEB2024. ON (B)(6) 2023, THE CUSTOMER ALSO PERFORMED A RETROSPECTIVE ANALYSIS AND HE RETESTED PATIENT SAMPLES USING VIDAS® B·R·A·H·M·S PCT¿ (LOT UNKNOWN). THE CUSTOMER REPORTED THAT THESE SIX PATIENT SAMPLES WERE THE ONLY ONES RAN DURING THE TIME FRAME OF THEIR ISSUE WITH SECTION A. SAMPLES WERE RERUN IN ANOTHER SECTION AND CORRECT RESULTS WERE OBTAINED AS FOLLOW: PATIENT A: (B)(6) 2023 (INITIAL RESULT): <0.05. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05 (NO IMPACT ON RESULT). PATIENT B: (B)(6) 2023 (INITIAL RESULT): 9.94. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): 0.20. PATIENT C: (B)(6) 2023 (INITIAL RESULT): 0.32. (B)(6) 2023 (RETESTED ON ANOTHER SECTION): <0.05. PATIENT D: (B)(6) 2023 (INITIAL RESULT):

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913826 ↗
• MalfunctionJun 26, 2023High Test Results; High Test Results

  INTENDED USE; THE MINI VIDAS® SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE MINI VIDAS® SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS® ASSAY KITS. AS PER THE USER MANUAL OF MINI VIDAS®: ¿QUALITY CONTROL VIDAS® (QCV) MUST BE RUN ON ALL THE MINI VIDAS® ANALYZER POSITIONS AT LEAST ONCE A WEEK OR ANYTIME THAT A PIPETTING PROBLEM IS SUSPECTED. THE QUALITY CONTROL VIDAS® (QCV) ALLOWS TO CHECK PIPETTE MECHANISMS OF THE SECTION PUMPS. FOLLOW THE INSTRUCTIONS IN THE VIDAS® QCV PACKAGE INSERT. TO ANALYZE THE RESULTS, REFER TO THE ¿RESULTS INTERPRETATION» SECTION IN THE VIDAS® QCV PACKAGE INSERT.¿ DESCRIPTION OF THE PROBLEM: ON (B)(6) 2023, A CUSTOMER IN UNITED-STATES NOTIFIED BIOMÉRIEUX OF QCV FAILURE OF MINI VIDAS BLUE 110 / 220 V (REF. 99737) LEADING TO OVERESTIMATED AND DELAYED RESULTS WHEN TESTING WITH VIDAS® B·R·A·H·M·S PCT¿ WITH A PATIENT SAMPLE. A CUSTOMER NOTICED A DRY SOLID PHASE RECEPTOR (SPR) IN POSITION A3 AFTER RUNNING A PROCALCITONIN (PCT) SAMPLE. SUSPECTING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200932 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923579. One submission often covers many models, so check the product and lot details in each record.

• Z-2429-2018 · Jan 4, 2018 · Terminated
  BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect