BD BACTEC™ FOS™ Culture Supplement Kit 442153Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382904421534), received between Jul 27, 2021 and Sep 2, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Contamination; Contamination

  IT WAS REPORTED WHILE USING BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN AN UNKNOWN QUANTITY OF MEDIA DURING QUALITY CONTROL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939680 ↗
• MalfunctionFeb 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, BACILLUS CONTAMINATION GROWTH WAS OBSERVED IN THE MEDIA INVOLVING TWO (2) DIFFERENT KIT BATCHES WHEN PROCESSING QUALITY CONTROL. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED AS PATIENT SAMPLES WERE NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332653 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BEFORE USING THE BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE MEDIA WAS OBSERVED TO BE CONTAMINATED AND CLOUDY. THIS EVENT OCCURRED WITH ONE (1) KIT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453214 ↗
• MalfunctionAug 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN MEDIA DURING QUALITY CONTROL TESTING. THE CONTAMINATION WAS TYPED AS BACILLUS USING MALDI-TOF TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975796 ↗
• MalfunctionApr 16, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT BIOLOGICAL CONTAMINATION WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115473 ↗
• MalfunctionNov 10, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT, FALSE NEGATIVE RESULT WAS OBTAINED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE CSF SAMPLE CSF SAMPLE INOCULATED IN BACTEC PEDS BOTTLE WITH FOS ADDED WAS NEGATIVE AFTER 5 DAYS OF INCUBATION, THE SAME SAMPLE WHEN INOCULATED DIRECTLY ON BLOOD AGAR PLATE GAVE GROWTH OF KLEBSIELLA PNEUMONIAE AFTER 24 HOURS. ALL PREPARATION PROCEDURES WERE RESPECTED.

  Patient problems: Insufficient Information

  MAUDE report 18109962 ↗
• MalfunctionJul 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 4 BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOTICEABLE CLOUDINESS ON 4 TUBES, DISCARDED AND NOT USED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229324 ↗