BACT/ALERT® BPA (UDI 03573026612047)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03573026612047), received between Jun 24, 2019 and Feb 2, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS (BACT/ALERT® 3D ANDBACT/ALERT® VIRTUO®) FOR QUALITY CONTROL TESTING OF LEUKOCYTE-REDUCED APHERESIS PLATELET (LRAP) UNITS, AND BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC). BACT/ALERT® BPA CULTURE BOTTLES SUPPORT THE GROWTH OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI). ISSUE DESCRIPTION: A BLOOD BANK CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF INSTRUMENT FALSE POSITIVE RESULTS WITH PLASMA PLATELETS SAMPLE IN ASSOCIATION WITH BACT/ALERT BPA US (REF. 423278, BATCH NUMBER 0001058875, EXPIRATION DATE 5/26/2023. THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, DIFFERENT PRODUCT : BACT/ALERT BPN BOTTLE). THE CUSTOMER PERFORMED SUBCULTURE, WHICH WERE NEGATIVE AND GRAM STAINING WAS ALSO NEGATIVE. THIS CASE IS SIMILAR TO A PRIOR CASE IN (B)(6) 2022 (B)(4) WHERE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED DEFINITIVELY, BUT IT IS LIKELY ASSOCIATED WITH THE SAMPLE TYPE (LEUKOCYTE-REDUCED PLATELETS). BIOMÉRIEUX GLOBAL INDUSTRY CUSTOMER SERVICE (GICS) WILL REVIEW THE DETAILS PROVIDED BY THE CUSTOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282388 ↗
• MalfunctionMar 17, 2022False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS (BACT/ALERT® 3D AND BACT/ALERT® VIRTUO®) FOR QUALITY CONTROL TESTING OF LEUKOCYTE-REDUCED APHERESIS PLATELET (LRAP) UNITS, AND BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC). BACT/ALERT® BPA CULTURE BOTTLES SUPPORT THE GROWTH OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI). BACT/ALERT® MICROBIAL DETECTION SYSTEMS ARE USED TO DETECT BACTERIA IN PLATELET COMPONENTS. BACT/ALERT® MICROBIAL DETECTION SYSTEMS ARE USED AS A SAFETY MEASURE, TO EXTEND DATING BEYOND DAY 5 AND UP TO DAY 7 FOR THE FOLLOWING: LARGE VOLUME DELAYED SAMPLING (LVDS) OF PLATELETS NO SOONER THAN 48 HOURS AFTER COLLECTION; OR SECONDARY CULTURE NO SOONER THAN DAY 4 AFTER PLATELET COLLECTION. BACT/ALERT® MICROBIAL DETECTION SYSTEMS ARE USED TO EXTEND DATING TO FIVE DAYS FOR THE FOLLOWING: LARGE VOLUME DELAYED SAMPLING (LVDS) OF PLATELETS NO SOONER THAN 36 HOURS AFTER COLLECTION; ORSECONDARY CULTURE NO SOONER THAN DAY 3 AFTER PLATELET COLLECTION. DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT WHILE TESTING BL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793979 ↗
• MalfunctionNov 10, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS (BACT/ALERT® 3D AND BACT/ALERT® VIRTUO®) FOR QUALITY CONTROL TESTING OF LEUKOCYTE-REDUCED APHERESIS PLATELET (LRAP) UNITS, AND BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC).1,2 BACT/ALERT® BPA CULTURE BOTTLES SUPPORT THE GROWTH OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI). DESCRIPTION OF THE PROBLEM: A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF SUSPECTED FALSE POSITIVE RESULTS (STRAINS NOT AVAILABLE AT THE TIME OF THIS ASSESSMENT) IN ASSOCIATION WITH BACT/ALERT BPA US (REF. 423278, BATCH NUMBER 0001057296, EXPIRATION DATE 7-APR-2022). THE CUSTOMER HAD EIGHT (8) POSITIVE BACT/ALERT BPA CULTURE BOTTLES WITH LOT # 0001057296 FROM BACT/ALERT DETECTION TESTING. THE CUSTOMER REPORTED THEY SENT THE EIGHT (8) POSITIVE CULTURE BOTTLES TO (B)(6) FOR ORGANISM IDENTIFICATION. IT IS UNKNOWN IF MULTIPLE PATIENTS ARE ASSOCIATED WITH THE CULTURE BOTTLES. IT WAS REPORTED THAT THE CUSTOMER HAS A NEW SAMPLING METHOD (LVDS) FOR INOCULATING THE BOTTLES AND THINKS THE ISSUE MAY BE RELATED TO THAT. HOWEVER, THERE IS NO DEFINITIVE EVIDENCE THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789649 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729479 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729478 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729477 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729464 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729463 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729462 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729447 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729446 ↗
• MalfunctionJun 24, 2019False Positive Result; False Positive Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR NINE (9) BOTTLES WHEN TESTING BLOOD PRODUCTS WITH THE BACT/ALERT® BPA US CULTURE BOTTLE (REF. 423278). THE POSITIVE RESULTS OCCURRED ON THE BACT/ALERT WITHIN THE FIVE-DAY TESTING PERIOD, BUT THE BLOOD PRODUCTS WERE RELEASED FOR USE 10 HOURS AFTER SAMPLED. THE PRODUCTS WERE TRANSFUSED BY THE TIME THE FALSE POSITIVE RESULTS OCCURRED. THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS FOR 11 BOTTLES. ALL OF THESE BOTTLES WERE SUBCULTURED. OF THESE, THE SUBCULTURE FOR BOTTLE PAS23C0Y GREW LISTERIA MONOCYTOGENES AA, AND THE SUBCULTURE FOR BOTTLE PAS23J44 GREW CORYNEBACTERIUM SPECIES A. THIS INDICATES THAT THESE TWO BOTTLES WERE TRUE POSITIVES. THE CUSTOMER REPORTED THAT THE OTHER NINE (9) BOTTLE SUBCULTURES WERE NEGATIVE FOR ORGANISM GROWTH. 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 WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729445 ↗