BACT/ALERT® BPA (UDI 03573026595975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026595975), received between Oct 12, 2017 and Nov 8, 2021 — classified as 3 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPA CULTURE BOTTLES (REF 279018) ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS FOR QUALITY CONTROL TESTING OF LEUKOCYTE REDUCED APHERESIS PLATELET (LRAP) UNITS, AND BOTH LEUKOCYTE REDUCED SINGLE AND A POOL 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). DESCRIPTION: A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN INCREASE IN FALSE POSITIVE RESULTS WITH THE BACT/ALERT® BPA (REF 279018, LOT 0001056651). THE CUSTOMER REPORTED OBTAINING AN INCREASED NUMBER OF FALSE POSITIVES WITH NO ASSOCIATED INSTRUMENT ERRORS. DATA FROM THE CUSTOMER INDICATED A FALSE POSITIVE RATE OF 0.648% FOR THE MONTH OF SEPTEMBER. AS AN EXAMPLE, A GRAPH FROM A BPA BOTTLE WAS PROVIDED FOR GLOBAL CUSTOMER SERVICE (GCS) REVIEW. THE BOTTLE CONTAINED PLATELET PRODUCTS, BETWEEN 8 AND 10 ML. THE PLATELETS WERE COLLECTED FROM SINGLE DONOR BY APHERESIS, FILTERING OUT THE WHITE BLOOD CELLS. THE GRAPH IMAGE SHOWS THE GRAPH OF BOTTLE ID PATS8NX0 WHICH WAS FLAGGED POSITIVE AT 1.13 DAYS. THE CHART SEEMS TO START AT 2269 RFU AND REACH 2623 RFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12769964 ↗
• InjuryMay 24, 2019False Negative Result; False Negative Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A PATIENT'S POST-TRANSFUSION REACTION. THE PLATELET PRODUCT HAD BEEN TESTED WITH THE BACT/ALERT® BPA CULTURE BOTTLE (REF 279018, LOT 1052346) AND OBTAINED A POTENTIALLY FALSE NEGATIVE RESULT. ON (B)(6) 2019, THE RECIPIENT OF LEUKO-REDUCED PLATELET PRODUCT HAD A POST-TRANSFUSION REACTION. THE PRODUCT WAS CULTURED AND FOUND POSITIVE FOR STREPTOCOCCUS MITIS (GRAM POSITIVE COCCI IN PAIRS AND CHAINS) IN THE AEROBIC BOTTLE. THE ANAEROBIC BOTTLE HAD NO GROWTH AT FIVE (5) DAYS. PER THE CUSTOMER REPORT, THE PLATELET PRODUCT HAD BEEN COLLECTED FROM THE DONOR ON (B)(6) 2019 AT THE (B)(6) BLOOD SERVICES COLLECTION AND PROCESSING CENTER. THE BPA CULTURE BOTTLE WAS INOCULATED WITH THE PLATELET PRODUCT SAMPLE AT THE CUSTOMER'S CENTER ON DAY 3, APPROXIMATELY 72 HOURS AFTER COLLECTION ((B)(6) 2019) AND WAS ENTERED IN TO THE BACT/ALERT 3D INSTRUMENT IMMEDIATELY AFTER INOCULATION. THE BACT/ALERT SYSTEM REPORTED A NEGATIVE RESULT ON (B)(6) 2019. THIS NEGATIVE CULTURE BOTTLE WAS DISCARDED PRIOR TO THE CUSTOMER'S NOTIFICATION OF THE TRANSFUSION REACTION EVENT. NO SUBCULTURE WAS PERFORMED ON THE BOTTLE PRIOR TO DISCARDING IT. THE PLATELET PRODUCT D

  Patient problems: Reaction

  MAUDE report 8641638 ↗
• DeathJul 30, 2018False Negative Result; False Negative Result

  DURING A POST-MARKET SURVEILLANCE REVIEW OF A JOURNAL ARTICLE TITLED "FATAL SEPSIS ASSOCIATED WITH BACTERIAL CONTAMINATION OF PLATELETS - UTAH AND CALIFORNIA, AUGUST 2017," DISCREPANT RESULTS WERE IDENTIFIED ASSOCIATED WITH BACT/ALERT® BPA (REFERENCE 279018). THE JOURNAL ARTICLE STATES THAT TWO (2) PATIENTS IN UTAH EXPIRED AFTER PLATELET TRANSFUSIONS FROM THE SAME DONATION. PATIENT 1: CLOSTRIDIUM PERFRINGENS ISOLATES FROM ONE PATIENT'S BLOOD. "IN AUGUST 2017, TWO (2) APHERESIS PLATELET UNITS AND ONE (1) UNIT OF PLASMA WERE MANUFACTURED FROM AN APHERESIS BLOOD DONATION IN UTAH. BOTH PLATELET UNITS WERE DISTRIBUTED TO HOSPITAL X, WHERE A MALE (PATIENT 1) WITH ACUTE MYELOID LEUKEMIA AND NEUTROPENIA RECEIVED ONE OF THE PLATELET UNITS. THIRTY (30) MINUTES AFTER TRANSFUSION, HE DEVELOPED RIGORS; TRANSFUSION-TRANSMITTED BACTERIAL INFECTION WAS NOT CONSIDERED THEN BECAUSE OF THE PATIENT'S COMPLEX MEDICAL HISTORY. THE PATIENT DIED FOUR (4) DAYS LATER. ANAEROBIC BLOOD CULTURES, OBTAINED SHORTLY AFTER TRANSFUSION, GREW C. PERFRINGENS FIVE (5) DAYS AFTER COLLECTION." PATIENT 2: PATIENT'S PLATELET BAG AND DONOR SKIN SWABS WERE HIGHLY RELATED BY WHOLE GENOME SEQUENCING (WGS). "FOURTEEN (14) HOUR

  Patient problems: Death

  MAUDE report 7730938 ↗
• DeathJul 30, 2018False Negative Result; False Negative Result

  DURING A POST-MARKET SURVEILLANCE REVIEW OF A JOURNAL ARTICLE TITLED "FATAL SEPSIS ASSOCIATED WITH BACTERIAL CONTAMINATION OF PLATELETS - POST-MARKET SURVEILLANCE REVIEW OF A JOURNAL ARTICLE TITLED "FATAL SEPSIS ASSOCIATED WITH BACTERIAL CONTAMINATION OF PLATELETS - (B)(6), (B)(6) 2017," DISCREPANT RESULTS WERE IDENTIFIED ASSOCIATED WITH BACT/ALERT® BPA (REFERENCE (B)(4)). PATIENT 1: CLOSTRIDIUM PERFRINGENS ISOLATES FROM ONE PATIENT'S BLOOD. "IN (B)(6) 2017, TWO (2) APHERESIS PLATELET UNITS AND ONE (1) UNIT OF PLASMA WERE MANUFACTURED FROM AN APHERESIS BLOOD DONATION IN (B)(6). BOTH PLATELET UNITS WERE DISTRIBUTED TO HOSPITAL X, WHERE A MALE (PATIENT 1) WITH ACUTE MYELOID LEUKEMIA AND NEUTROPENIA RECEIVED ONE OF THE PLATELET UNITS. THIRTY (30) MINUTES AFTER TRANSFUSION, HE DEVELOPED RIGORS; TRANSFUSION-TRANSMITTED BACTERIAL INFECTION WAS NOT CONSIDERED THEN BECAUSE OF THE PATIENT'S COMPLEX MEDICAL HISTORY. THE PATIENT DIED FOUR (4) DAYS LATER. ANAEROBIC BLOOD CULTURES, OBTAINED SHORTLY AFTER TRANSFUSION, GREW C. PERFRINGENS FIVE (5) DAYS AFTER COLLECTION." PATIENT 2: PATIENT'S PLATELET BAG AND DONOR SKIN SWABS WERE HIGHLY RELATED BY WHOLE GENOME SEQUENCING (WGS). "FOURTEEN (14) HOU

  Patient problems: Death

  MAUDE report 7730929 ↗
• DeathOct 12, 2017False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES REPORTED TO BIOMÉRIEUX DISCREPANT RESULTS ASSOCIATED WITH THE BACT/ALERT® BPA CULTURE BOTTLE. THE CUSTOMER REPORTED HAVING TWO TRANSFUSION SAMPLES THAT DID NOT SHOW POSITIVE WHEN THEY WERE RUN. THE CUSTOMER STATED THAT THEY WERE TESTING BLOOD PLATELETS IN THE BPA BOTTLES AND HAVE RECEIVED A FALSE NEGATIVE RESULT. THE ORGANISM WAS IDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE PATIENT WHO RECEIVED THE PLATELETS HAD AN ADVERSE REACTION DUE TO THE RELEASE OF PRODUCT TESTED ON BIOMÉRIEUX EQUIPMENT. IT IS UNKNOWN IF THE PATIENT HAD ANY TREATMENT DUE TO THIS ADVERSE REACTION. AN INVESTIGATION WILL BE INITIATED BY BIOMÉRIEUX.

  Patient problems: Chills; Nausea; Reaction; Tachycardia; Vomiting

  MAUDE report 6945216 ↗