BACT/ALERT® BPN (UDI 03573026614157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026614157), received between Dec 29, 2021 and Feb 1, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPN 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® BPN CULTURE BOTTLES SUPPORT THE GROWTH OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA). 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 BPN US (REF. (B)(4), BATCH NUMBER 0001058889, EXPIRATION DATE 1-JUN-2023). THIS COMPLAINT IS RELATED TO THE COMPLAINT CN-456118 (SAME CUSTOMER, SAME ISSUE, DIFFERENT PRODUCT : BACT/ALERT BPA 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 (CN-354152) 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 D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276337 ↗
• MalfunctionJul 7, 2022False Positive Result; False Positive Result

  INTENDED USE: BACT/ALERT® BPN 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® BPN CULTURE BOTTLES SUPPORT THE GROWTH OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA). ISSUE DESCRIPTION: A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF SUSPECTED FALSE POSITIVE RESULTS IN ASSOCIATION WITH BACT/ALERT BPN US (REF. 423279, BATCH NUMBER 0001057610, EXPIRATION DATE 23-JUN-2022). THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4). (SAME CUSTOMER, SAME ISSUE, DIFFERENT PRODUCT : BACT/ALERT BPA BOTTLE). AT THE TIME OF COMPLAINT (B)(4) BEING REPORTED, THE CUSTOMER REPORTED HAVING 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 LABCORP FOR ORGANISM IDENTIFICATION. IT WAS REPORTED THAT THE CUSTOMER HAS A NEW SAMPLING METHOD (LVDS) OF INOCULATING THE BOTTLES AND THINKS THE ISSUE MAY BE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945931 ↗
• MalfunctionDec 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR A PLATELET SAMPLE IN ASSOCIATION WITH BACT/ALERT® BPN US (REF 423279, BATCH NUMBER NOT REPORTED, EXPIRATION DATE UNKNOWN). THE CUSTOMER DREW THREE PLATELET SAMPLES WHICH WERE FLAGGED POSITIVE ON THE FIRST AND THIRD RUN. SUB-CULTURE OF THE SAMPLES INDICATED NO GROWTH. THESE TWO FALSE POSITIVE SAMPLES WERE FROM THE SAME DONOR. IT WAS REPORTED THERE WAS NO PATIENT IMPACT; THE APHERESIS PLATELET PRODUCTS WERE RECALLED AND DESTROYED. IT WAS REQUESTED IF THE PHYSICIAN PRESCRIBED ANY ANTIBIOTICS TO THE PATIENT. THE REPLY WAS THAT THE PATIENT WAS NOT TRANSFUSED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110924 ↗