BACT/ALERT® BPN (UDI 03573026595999)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03573026595999), received between Jun 1, 2018 and Mar 22, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF TWO FALSE POSITIVE RESULTS WHILE USING BACT/ALERT ® BPN BOTTLES (REFERENCE# 279019 LOT# 1051492). THESE BOTTLES FLAGGED POSITIVE AND WERE SUB-CULTURED. THEY DID NOT EXHIBIT GROWTH, WHICH INDICATED FALSE POSITIVE RESULTS. THE CUSTOMER CONFIRMED THAT THEY ARE FOLLOWING THE INSTRUCTIONS FOR USE AND DID NOT NOTE ANY ANOMALIES WITH SAMPLE PREPARATION OR THE BOTTLES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444841 ↗
• MalfunctionMar 22, 2019False Positive Result; False Positive Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF TWO FALSE POSITIVE RESULTS WHILE USING BACT/ALERT ® BPN BOTTLES (REFERENCE# 279019 LOT# 1051492). THESE BOTTLES FLAGGED POSITIVE AND WERE SUB-CULTURED. THEY DID NOT EXHIBIT GROWTH, WHICH INDICATED FALSE POSITIVE RESULTS. THE CUSTOMER CONFIRMED THAT THEY ARE FOLLOWING THE INSTRUCTIONS FOR USE AND DID NOT NOTE ANY ANOMALIES WITH SAMPLE PREPARATION OR THE BOTTLES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444840 ↗
• MalfunctionMar 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT WHEN USING THE BACT/ALERT® BPN BOTTLE. THE BOTTLE (ID (B)(4)) WAS LOADED ON (B)(6) 2019 AND FLAGGED AS NEGATIVE ON (B)(6) 2019. THE BOTTLE WAS THEN UNLOADED (B)(6) 2019, AND THE CELL INDICATOR WAS OBSERVED AS YELLOW. THE GRAPH INDICATED GROWTH AND FINISHED OVER 4000. THE BOTTLE WAS SUBCULTURED AND CONTAINED FACULTATIVE ANAEROBIC GRAM NEGATIVE SPHERE BACILLI. THE LOCAL FIELD SERVICE ENGINEER (FSE) HAD PREVIOUSLY VISITED THE SITE AND CHECKED THE INSTRUMENT CONDITION AND FOUND NO ISSUE. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383610 ↗
• MalfunctionJun 1, 2018False Negative Result; False Negative Result

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH BACT/ALERT® BPN BOTTLE (REFERENCE 279019). THE CUSTOMER REPORTED DURING TESTING, 19 OUT OF 20 BOTTLES WERE POSITIVE, AND ONE (1) BOTTLE WAS NEGATIVE. ALL 20 BOTTLES WERE SUB-CULTURED ON PLATES AND GREW P. ACNES, INCLUDING THE BOTTLE THAT FLAGGED NEGATIVE AFTER FIVE (5) DAYS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7559937 ↗