EMAG® 418591Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 03573026471859), received between Oct 19, 2017 and Dec 10, 2025 — classified as 2 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (21 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Low Sensing Threshold; Low Sensing Threshold

  ON (B)(6) 2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (CODE 10076) LEADING TO DELAY IN RESULTS WHEN USING EMAG INSTRUMENT, REFERENCE # (B)(4), SERIAL NUMBER (B)(6). THE CUSTOMER EXPLAINED THAT THE ERROR 10075 USS LOW SENSING ERROR IS OCCURRING AT LEAST ONCE ON EVERY EXTRACTION ON BOTH SIDES OF THE INSTRUMENT. THIS REQUIRES THE CUSTOMER TO REPEAT THE TEST AND THE RESULTS FOR PATIENTS ARE DELAYED 24 HOURS IN SOME CASES. THE NUMBER OF PATIENTS INVOLVED HAS NOT BEEN PROVIDED. A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND REPLACED ALL QUICK CONNECT REAGENT FITTINGS INSIDE SYSTEM AND THE INSTRUMENT IS BEING MONITORED BY THE CUSTOMER FOR ANY FURTHER ISSUES. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772190 ↗
• MalfunctionNov 24, 2025Low Sensing Threshold; Low Sensing Threshold

  ON 10-NOV-2025, A CUSTOMER IN UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (CODE 10076) LEADING TO DELAY IN RESULTS WHEN USING EMAG INSTRUMENT (REFERENCE 418591, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT THEY OBSERVE ERROR CODE 10076 (ULTRASOUND READING BELOW THRESHOLD) RANDOMLY. THE CUSTOMER HAD TWO (2) SAMPLES ABORTED. ONE WAS A CSF SAMPLE AND THE OTHER SAMPLE WAS AN EYE SWAB IN MOLECULAR SAMPLE SOLUTION (MSS). THE NUMBER OF PATIENTS INVOLVED IS NOT KNOWN. BOTH SAMPLES WERE RE-EXTRACTED THE FOLLOWING DAY ON EMAG RIGHT SECTION. RESULTS WERE DELAYED BY 24 HOURS BUT WERE REPORTED WITHIN TWO (2) DAYS OF RECEIPT OF THE SAMPLES IN THE LABORATORY. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633165 ↗
• MalfunctionNov 17, 2025Short Fill; Short Fill

  PRODUCT DESCRIPTION THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ON (B)(6) 2025, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (LIQUID LEVEL DETECTION ISSUE) WHEN USING EMAG INSTRUMENT (REF. (B)(4), SERIAL NO. (B)(6)) LEADING TO DELAYED RESULTS. FROM (B)(6) 2025, THE CUSTOMER LAUNCHED RUNS WITH EMAG INSTRUMENT AND OBTAINED THIRTY-EIGHT (38) SAMPLE¿S RUNS INVALIDATED BY ERROR 14002 ¿ NO LIQUID DETECTED BY PIPETTOR DURING ELUATE TRANSFER IN OUTPUT TUBES. DUE TO THIS ISSUE, THE CUSTOMER REPORTED A DELAY IN RESULTS > 24 HOURS. IT IS TO BE NOTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575894 ↗
• MalfunctionAug 22, 2025High Sensing Threshold; High Sensing Threshold

  PRODUCT DESCRIPTION: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON 06-AUG-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING MULTIPLE ERROR CODES WHEN EXTRACTING PATIENT SAMPLES WITH THEIR EMAG INSTRUMENT (REF. 418591, SERIAL NUMBER: (B)(6)). CUSTOMER STATES THEY ARE HAVING ULTRASOUND SENSOR ISSUES ERROR CODES 10076,10077, 20253. CUSTOMER STATES THE ISSUES ARE ON BOTH SIDES OF THE INSTRUMENT AND IT HAS BEEN AN ONGOING ISSUE BUT RECENTLY IT HAS GOTTEN WORSE. CUSTOMER WAS INSTRUCTED TO DO AN EXTRACTION BUFFER 3 (EB3) CLEANING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877529 ↗
• MalfunctionJul 21, 2025Failure to Transmit Record; Failure to Transmit Record

  ON (B)(6) 2025, A CUSTOMER FROM SPAIN NOTIFIED BIOMÉRIEUX OF OBTAINING AN ERROR 20160 WHEN USING EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6) LEADING TO DELAYED RESULT. THE CUSTOMER REPORTED OBTAINING ERROR 20160 DURING AN EXTRACTION RUN. IT WAS NOT SPECIFIED WHETHER THIS WAS A PUNCTUAL OR RECURRING ERROR. DUE TO THIS ISSUE, THE CUSTOMER HAD TO REPEAT THE EXTRACTION FOR SOME SAMPLES (NUMBER OF IMPACTED PATIENTS NOT SPECIFIED), RESULTING IN A ONE-DAY DELAY IN REPORTING PATIENT RESULTS. AND FOR SOME SAMPLES (NUMBER OF IMPACTED PATIENTS NOT SPECIFIED), THE SAMPLE VOLUME WAS NOT SUFFICIENT TO REPEAT THE EXTRACTION, SO THE DELAY WAS ONE TO TWO WEEKS UNTIL A NEW SAMPLE WAS COLLECTED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAYED RESULT LED TO ANY ADVERSE EVENT RELATED TO PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554993 ↗
• MalfunctionJul 15, 2025Separation Failure; Separation Failure

  PRODUCT DESCRIPTION ************ THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION ************ ON 07-JUL-2025, A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING MULTIPLE ERROR CODES WHEN EXTRACTING PATIENT SAMPLES WITH EMAG (REF. 418591, SERIAL NUMBER: (B)(6). THE CUSTOMER RECEIVED THE FOLLOWING ERRORS DURING A WHOLE BLOOD EXTRACTION ON THE RIGHT SIDE OF THE EMAG: 24010, 14001, 24022, 24018, 24012. AFTER ABORTING THE RUN, THEY ALSO NOTICED THAT THE EDTA TUBE WAS PULLED UP IN ITS SAMPLE RACK AND THAT BLOOD WAS IN ONE OF THE WATER BLANKS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508665 ↗
• MalfunctionJun 12, 2025Failure to Transmit Record; Failure to Transmit Record

  PRODUCT DESCRIPTION *********************** THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION ******************** ON 04-JUN-2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (ERROR CODE 20160) LEADING TO A DELAY IN PATIENT RESULTS WHEN USING EMAG® SYSTEM REFERENCE (B)(4) SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED ISSUES WITH ERROR 20160: COMMUNICATION FAILURE BETWEEN HEATER BOARD AND PROCESS LANE BOARD AND 20146: DISPENSE PUMP MICROS STEP DRIVER COMM FAILURE ON THEIR EMAG SYSTEM. FIELD SERVICE ENGINEER (FSE) WAS ON SITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197263 ↗
• MalfunctionMar 12, 2025Pressure Problem; Pressure Problem

  PRODUCT DESCRIPTION: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD PARTY APPLICATIONS AND/OR THIRD PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON 05-MAR-2025, A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING AN ERROR (ERROR 10066) WHEN USING EMAG INSTRUMENT (REF. 418591, SERIAL NUMBER: (B)(6)) LEADING TO THE LOSS OF PATIENT SAMPLES. THE CUSTOMER HAS BEEN HAVING RECURRENT ISSUES WITH THE RIGHT SECTION OF THEIR EMAG INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) INTERVENED AND WAS ABLE TO STOP ERRORS (10076/10077) BUT THE CUSTOMER IS STILL GETTING SAME ERROR 10066 AT THE LAST WASHING STEP ON THE PROTOCOL. THE CU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584748 ↗
• MalfunctionJan 31, 2025Failure to Align; Failure to Align

  INTENDED USE: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A LOSS OF SAMPLES AND THEREFORE A DELAY WHEN USING EMAG® INSTRUMENT (REF. (B)(4), SERIAL NUMBER: (B)(6). AFTER LAUNCHING THE RUNS, THE CUSTOMER¿S EMAG INSTRUMENT HAD AN ASPIRATION ISSUE. BECAUSE OF THE ISSUE AND THE TROUBLESHOOTING THAT HAPPENED AFTER, THE CUSTOMER RAN OUT OF FIVE SAMPLES (FOUR PATIENTS). IN CONSEQUENCE, HE IS GOING TO HAVE TO REQUEST A RECOLLECTION FOR THESE SAMPLES. ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285586 ↗
• MalfunctionJan 31, 2025Failure to Align; Failure to Align

  INTENDED USE: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A LOSS OF SAMPLES AND THEREFORE A DELAY WHEN USING EMAG® INSTRUMENT (REF. 418591, SERIAL NUMBER: (B)(6). AFTER LAUNCHING THE RUNS, THE CUSTOMER¿S EMAG INSTRUMENT HAD AN ASPIRATION ISSUE. BECAUSE OF THE ISSUE AND THE TROUBLESHOOTING THAT HAPPENED AFTER, THE CUSTOMER RAN OUT OF FIVE SAMPLES (FOUR PATIENTS). IN CONSEQUENCE, HE IS GOING TO HAVE TO REQUEST A RECOLLECTION FOR THESE SAMPLES. ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285568 ↗
• MalfunctionJan 31, 2025Failure to Align; Failure to Align

  INTENDED USE. THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD PARTY APPLICATIONS AND/OR THIRD PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON (B)(6) 2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A LOSS OF SAMPLES AND THEREFORE A DELAY WHEN USING EMAG® INSTRUMENT (REF. (B)(4)., SERIAL NUMBER: (B)(6). AFTER LAUNCHING THE RUNS, THE CUSTOMER¿S EMAG INSTRUMENT HAD AN ASPIRATION ISSUE. BECAUSE OF THE ISSUE AND THE TROUBLESHOOTING THAT HAPPENED AFTER, THE CUSTOMER RAN OUT OF FIVE SAMPLES (FOUR PATIENTS). IN CONSEQUENCE, HE IS GOING TO HAVE TO REQUEST A RECOLLECTION FOR THESE SAMPLES. ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285532 ↗
• MalfunctionJan 31, 2025Failure to Align; Failure to Align

  INTENDED USE. THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD PARTY APPLICATIONS AND/OR THIRD PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION: ON 09-JAN-2025, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A LOSS OF SAMPLES AND THEREFORE A DELAY WHEN USING EMAG® INSTRUMENT (REF. 418591, SERIAL NUMBER: (B)(6)). AFTER LAUNCHING THE RUNS, THE CUSTOMER¿S EMAG INSTRUMENT HAD AN ASPIRATION ISSUE. BECAUSE OF THE ISSUE AND THE TROUBLESHOOTING THAT HAPPENED AFTER, THE CUSTOMER RAN OUT OF FIVE SAMPLES (FOUR PATIENTS). IN CONSEQUENCE, HE IS GOING TO HAVE TO REQUEST A RECOLLECTION FOR THESE SAMPLES. ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285503 ↗
• MalfunctionSep 10, 2024Defective Component; Defective Component

  PRODUCT DESCRIPTION: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD-PARTY APPLICATIONS AND/OR THIRD-PARTY COMMERCIAL KITS. THE EMAG® SYSTEM IS INTENDED FOR USE BY LABORATORY HEALTH PROFESSIONALS ONLY. ISSUE DESCRIPTION ON 04-SEP-2024, A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A DELAY IN PATIENT RESULTS WHEN USING EMAG® SYSTEM REFERENCE (B)(4). SERIAL NUMBER (B)(6). ACCORDING TO THE RUN REPORTS, THE WERE 2 DISTINCT ERRORS ON THE LEFT (LHS) SECTION OF THE INSTRUMENT. - ERROR 20143 MICROSTEP DRIVER [AXIS-0] COMMUNICATION FAILURE - ERROR 10065 AB ASPIRATION THRESHOLD TIMEOUT MEANING THAT UNEXPECTED PRESSURE VALUE DETECTED IN THE ASPIRATION CIRCUIT (<-45 KPA)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181465 ↗
• MalfunctionAug 6, 2024Short Fill; Short Fill

  ISSUE DESCRIPTION: ON 23-JUL-2024, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO DELAYED RESULTS WHEN USING EMAG INSTRUMENT (REFERENCE (B)(4) , SERIAL NUMBER (B)(6)). THE RESULTS WERE DELAYED FOR 24 HOURS BECAUSE THE IC (REQUIRED TO VALIDATE A RESULT) WAS NOT COMPLIANT. PATIENTS WERE UNABLE TO OBTAIN THEIR RESULTS UNTIL THE FOLLOWING DAY, AFTER A NEW EXTRACTION. THE NUMBER OF PATIENTS INVOLVED IS NOT KNOWN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAYED RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920177 ↗
• MalfunctionJun 28, 2024Low Sensing Threshold; Low Sensing Threshold

  ON 20-JUN-2024, A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (CODE 10076) LEADING TO DELAY IN RESULTS WHEN USING EMAG INSTRUMENT (REFERENCE 418591, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THAT THEY OBSERVE ERROR CODE 10076 (ULTRASOUND READING BELOW THRESHOLD) RANDOMLY. THIS HAS LED TO A FOUR (4) DAY DELAY IN REPORTING RESULTS FOR AN INFECTIOUS DISEASE CSF SAMPLE. THE CUSTOMER HAS PROVIDED RUN LOGS TO BE REVIEWED BY GLOBAL CUSTOMER SERVICE (GCS). GCS NOTED THE ERROR 10076 IS OCCURRING ON POSITION 2 AFTER THE LAST ASPIRATION WITH THE BUFFER#3 AND THE USS IS READING A VOLUME OF 575 L OF LIQUID (INSTEAD OF 30 L). AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633082 ↗
• MalfunctionJun 7, 2024Defective Component; Defective Component

  PRODUCT DESCRIPTION: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. THE EMAG® SYSTEM HAS BEEN VALIDATED WITH BIOMÉRIEUX REAGENTS AND APPLICATIONS. BIOMÉRIEUX IS NOT RESPONSIBLE FOR THE VALIDATION OF THIRD PARTY APPLICATIONS AND/OR THIRD PARTY COMMERCIAL KITS. ISSUE DESCRIPTION: ON (B)(6) 2024, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR LEADING TO A DELAY IN RESULTS WHEN USING EMAG®REFERENCE 418591 SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED LYSIS BUFFER OVERFLOWING ON RIGHT SIDE OF EMAG, LEADING THEM TO FORCE SHUTDOWN OF THE INSTRUMENT. AFTER INVESTIGATION ON SITE BY FSE, THE ISSUE WAS FOUND TO BE RELATED TO A WEAKNESS OF A QUICK CONNECTOR ON THE DISPENSE LINE, LEADING TO BUFFER LEAKAGE INSIDE THE INSTRUMENT. THE INSTRUMENT WAS REPAIRED, CLEANED, AND RELEASED FOR USE. AT THE TIME OF THIS ASSESSMENT, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491745 ↗
• MalfunctionMar 21, 2024Pressure Problem; Pressure Problem

  ON (B)(6) 2024, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING AN ASPIRATION ERROR (ERROR 10065) WHEN USING EMAG (REF. (B)(6), SERIAL NUMBER: (B)(6)) LEADING TO THE LOSS OF PATIENT SAMPLES. ON (B)(6) 2024, THE CUSTOMER OBTAINED AN ERROR 10065 ON THE RIGHT SECTION OF THE EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6)). DUE TO THIS ISSUE, THE CUSTOMER SPECIFIED THE LOSS OF TWO (2) SAMPLES BECAUSE OF THE ERROR CODE. IN THE CASE, THE TWO SAMPLES CORRESPOND TO AQUEOUS HUMOR AND CSF (CEREBROSPINAL FLUID) WITH A VERY LOW VOLUME COLLECTED. THE CUSTOMER WAS UNABLE TO PERFORM ANOTHER ANALYSIS AS THE CUSTOMER HAD NO SAMPLE LEFT. THE CUSTOMER RETURNED THE TEST AS NOT PERFORMED BECAUSE THE QUANTITY WAS INSUFFICIENT. A NEW SAMPLE WILL THEREFORE HAVE TO BE COLLECTED. TO BE NOTED THAT THE CUSTOMER EXPERIENCED THE SAME ISSUE (ERROR 10065) ON THE LEFT SECTION OF THE EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6)) WITHOUT ANY PATIENT IMPACT. AN FSE WAS DISPATCH ON CUSTOMER SITE ON (B)(6) 2024. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949817 ↗
• MalfunctionMar 21, 2024Pressure Problem; Pressure Problem

  ON (B)(6) 2024, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING AN ASPIRATION ERROR (ERROR 10065) WHEN USING EMAG (REF. (B)(4) , SERIAL NUMBER: (B)(6) LEADING TO THE LOSS OF PATIENT SAMPLES. ON (B)(6)2024, THE CUSTOMER OBTAINED AN ERROR 10065 ON THE RIGHT SECTION OF THE EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6). DUE TO THIS ISSUE, THE CUSTOMER SPECIFIED THE LOSS OF TWO (2) SAMPLES BECAUSE OF THE ERROR CODE. IN THE CASE, THE TWO SAMPLES CORRESPOND TO AQUEOUS HUMOR AND CSF (CEREBROSPINAL FLUID) WITH A VERY LOW VOLUME COLLECTED. THE CUSTOMER WAS UNABLE TO PERFORM ANOTHER ANALYSIS AS THE CUSTOMER HAD NO SAMPLE LEFT. THE CUSTOMER RETURNED THE TEST AS NOT PERFORMED BECAUSE THE QUANTITY WAS INSUFFICIENT. A NEW SAMPLE WILL THEREFORE HAVE TO BE COLLECTED. TO BE NOTED THAT THE CUSTOMER EXPERIENCED THE SAME ISSUE (ERROR 10065) ON THE LEFT SECTION OF THE EMAG (REF. (B)(4), SERIAL NUMBER: (B)(6) WITHOUT ANY PATIENT IMPACT. AN FSE WAS DISPATCH ON CUSTOMER SITE ON (B)(6) 2024. 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. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949784 ↗
• MalfunctionJan 25, 2024Contamination; Contamination

  ON (B)(6) 2024, A CUSTOMER FROM UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS DUE TO A CONTAMINATION LEADING TO DELAYED RESULTS WITH EMAG® (REF. (B)(4), SERIAL NUMBER (B)(6)). THE CUSTOMER DID A RUN ON (B)(6) 2023 AND DEEMED CONTAMINATED SINCE ALL RESULTS WERE POSITIVE. THE CUSTOMER RERAN THE BATCH AND EVEN NEGATIVE CONTROL WAS POSITIVE (CMV CONTROLS ARE MADE MANUALLY BY STAFF). NO RESULTS WERE REPORTED OUT. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE REFERENCED ISSUE. HOWEVER, THERE WAS A DELAY IN 24 PATIENTS (22 CMV, 2 HHV6) OF MORE THAN 48 HOURS DUE TO HAVING TO SEND THE SAMPLES OUT. THE PRODUCT, EMAG SYSTEM REFERENCE (B)(4), IS MARKETED, SOLD AND DISTRIBUTED IN THE UNITED STATES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578396 ↗
• MalfunctionJan 3, 2024Low Sensing Threshold; Low Sensing Threshold

  PRODUCT DESCRIPTION THE EMAG SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). ISSUE DESCRIPTION ON 21-DEC-2023, A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF AN INSTRUMENT ERROR (CODE 10076) LEADING TO DELAY IN RESULTS WHEN USING EMAG SYSTEM REFERENCE 418591, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED FOUR (4) FAILURES OVER THREE (3) CARTRIDGES ON THE LEFT SIDE OF THE EMAG. THE FAILURES ARE ERROR CODE 10076 (ULTRASOUND READING BELOW THRESHOLD). AT THE TIME OF THIS ASSESSMENT, THERE WAS NO INDICATION OF PATIENT HARM OR INCORRECT TREATMENT. THE CUSTOMER DID INDICATE DELAY OF ~2 DAYS (48 HOURS) AS THE IMPACTED SAMPLES NEEDED TO BE RE-PREPARED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440133 ↗
• MalfunctionDec 5, 2023Low Sensing Threshold; Low Sensing Threshold

  ON 16-NOV-2023, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING AN ERROR THAT LEAD TO AN ABORTED RUN WHEN USING THE EMAG (REF. (B)(4), SERIAL NUMBER (B)(6). ON (B)(6) 2023, THE CUSTOMER HAD AN ERROR 10076 (USS VALUE BELOW TRESHOLD -LOW SENSING THRESHOLD) WITH ONE SAMPLE IN LEFT SECTION. IT WAS LCR. THE RUN ABORTED AND THE CUSTOMER NO LONGER HAS THE SAMPLE. ACCORDING TO THE EMAG USER MANUAL, ERROR 10076 MEANS "THE VALUE READ BY THE ULTRASOUND SENSOR IS TOO LOW, INDICATING TOO MUCH LIQUID IS PRESENT IN THE WELL." USERS ARE INSTRUCTED TO "REINITIALIZE THE CORRESPONDING SECTION. IF THE ISSUE PERSISTS, CONTACT BIOMÉRIEUX." ON (B)(6) 2023, THERE WAS AN ERROR 10077 (USS VALUE ABOVE THRESHOLD - HIGH SENSING THRESHOLD) ON THE LEFT SECTION. ACCORDING TO THE EMAG USER MANUAL, ERROR 10077 MEANS "THE VALUE READ BY THE ULTRASOUND SENSOR IS TOO HIGH, INDICATING A LACK OF VOLUME IS PRESENT IN THE WELL." USERS ARE INSTRUCTED TO "REINITIALIZE THE CORRESPONDING SECTION. IF THE ISSUE PERSISTS, CONTACT BIOMÉRIEUX." THE CUSTOMER PROVIDED RUN LOGS TO BE REVIEWED BY CUSTOMER SERVICE. THEIR REVIEW SUGGESTED THE 10077 ERROR HAPPENED AT THE SAME TIME ON ALL SAMPLE POSITIONS SO IT WAS MOST LIKELY DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267921 ↗
• MalfunctionDec 5, 2023Low Sensing Threshold; Low Sensing Threshold

  ON 16-NOV-2023, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING AN ERROR THAT LEAD TO AN ABORTED RUN WHEN USING THE EMAG (REF.(B)(4), SERIAL NUMBER (B)(6). ON (B)(6) 2023, THE CUSTOMER HAD AN ERROR 10076 (USS VALUE BELOW TRESHOLD -LOW SENSING THRESHOLD) WITH ONE SAMPLE IN LEFT SECTION. IT WAS LCR. THE RUN ABORTED AND THE CUSTOMER NO LONGER HAS THE SAMPLE. ACCORDING TO THE EMAG USER MANUAL, ERROR 10076 MEANS "THE VALUE READ BY THE ULTRASOUND SENSOR IS TOO LOW, INDICATING TOO MUCH LIQUID IS PRESENT IN THE WELL." USERS ARE INSTRUCTED TO "REINITIALIZE THE CORRESPONDING SECTION. IF THE ISSUE PERSISTS, CONTACT BIOMÉRIEUX." ON (B)(6) 2023, THERE WAS AN ERROR 10077 (USS VALUE ABOVE THRESHOLD - HIGH SENSING THRESHOLD) ON THE LEFT SECTION. ACCORDING TO THE EMAG USER MANUAL, ERROR 10077 MEANS "THE VALUE READ BY THE ULTRASOUND SENSOR IS TOO HIGH, INDICATING A LACK OF VOLUME IS PRESENT IN THE WELL." USERS ARE INSTRUCTED TO "REINITIALIZE THE CORRESPONDING SECTION. IF THE ISSUE PERSISTS, CONTACT BIOMÉRIEUX." THE CUSTOMER PROVIDED RUN LOGS TO BE REVIEWED BY CUSTOMER SERVICE. THEIR REVIEW SUGGESTED THE 10077 ERROR HAPPENED AT THE SAME TIME ON ALL SAMPLE POSITIONS SO IT WAS MOST LIKELY DUE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267908 ↗
• MalfunctionNov 30, 2023Failure to Transmit Record; Failure to Transmit Record

  INTENDED USE. THE EMAG SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). DESCRIPTION OF THE ISSUE. ON 22-NOV-2023, A CUSTOMER IN BELGIUM NOTIFIED BIOMÉRIEUX OF A DELAY IN RENDERING THE RESULT DUE TO A RUN ABORTION DURING NUCLEIC ACID EXTRACTION WHEN USING EMAG® (REF. (B)(4), SERIAL NUMBER: (B)(6). THE CUSTOMER LAUNCHED A NUCLEIC ACID EXTRACTION ON 22-NOV-2023 FROM TWENTY FOUR (24) SAMPLES. DURING THE RUN, AN ISSUE OCCURRED THAT TRIGGERED THE ERROR CODE 20160 LEADING TO THE RUN ABORTION. AMONG THE 24 SAMPLES, ONE WAS TOTALLY LOST DURING THE INCIDENT LEADING TO A DELAY BECAUSE A NEW SAMPLING HAS TO BE MADE. AT THIS TIME OF THE ASSESSMENT, THE LENGTH OF THE DELAY IS NOT KNOWN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235747 ↗
• MalfunctionOct 11, 2023Contamination; Contamination

  INTENDED USE: THE EMAG® SYSTEM IS AN IN VITRO DIAGNOSTIC MEDICAL DEVICE INTENDED FOR THE AUTOMATED ISOLATION (PURIFICATION AND CONCENTRATION) OF TOTAL NUCLEIC ACIDS (RNA/DNA) FROM BIOLOGICAL SPECIMENS, WITH LIQUID AND HOMOGENEOUS PROPERTIES (AS PART OF THEIR NATURAL CHARACTERISTICS OR AFTER PRE-TREATMENT). FOR IN VITRO DIAGNOSTIC APPLICATIONS, THE EMAG® SYSTEM IS INTENDED TO BE USED IN CLINICAL LABORATORIES ONLY. ISSUE DESCRIPTION ON 15-SEP-2023, A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF OBTAINING CONTAMINATION WHEN TESTING WITH EMAG (REF.(B)(4), SERIAL NUMBER (B)(6)). THE CUSTOMER DETECTED CUTIBACTERIUM ACNES IN NEGATIVE EXTRACTION CONTROL. HE TESTED ALSO THREE (3) PATIENT SAMPLES AND HE CONFIRMED THAT THEY WERE NEGATIVE FOR CUTIBACTERIUM ACNES, THUS NO CONTAMINATION IMPACT WITH THE PATIENT SAMPLES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914431 ↗
• MalfunctionFeb 24, 2023Failure to Transmit Record; Failure to Transmit Record

  ON (B)(6) 2023, A CUSTOMER IN UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF SAMPLE PROCESSING ABORTION LEADING TO NO RESULT AND DELAYED RESULTS WHEN USING THE EMAG® (REF. 418591, SERIAL NUMBER: (B)(4)) WITH A PATIENT SAMPLE. DURING THE EXTRACTION PROCESS, THE ERROR CODE 20160 OCCURRED. THE CUSTOMER SPECIFIED THAT THIS ERROR HAS CAUSED THE LOSS OF A MYCOBACTERIA SAMPLE, WHICH HE CANNOT REPEAT. IT HAS TO BE RE-GROWN, WHICH CAN TAKE WEEKS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE 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 16436751 ↗