BD BACTEC™ Standard Anaerobic/F Culture Vials 442191Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382904421915), received between Jan 25, 2021 and Oct 13, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K915796); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 3 BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS FROM LOT 1027294, AND 2 BOTTLES FROM LOT 1061248 PRODUCED FALSE POSITIVE RESULTS WITH THE BACTEC MEDIA. GRAM STAINS WERE TESTED, WHICH PRODUCED NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD 5 FALSE POSITIVES FLAG RECENTLY. NOTHING SEEN IN GRAM STAINS. NO TEMPERATURE ISSUES NOTED. ONLY ONE PATIENT HAD A HIGH WBC. CUSTOMER DOES NOT BELIEVE THE BOTTLES WERE OVERFILLED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620720 ↗
• MalfunctionMay 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC" STANDARD ANAEROBIC/F CULTURE VIALS 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD CULTURE BOTTLES FLAGGED POSITIVE BUT NO BACTERIA SEEN ON THE SMEAR. PLEASE VERIFY IF THERE WAS ANY PATIENT IMPACT - WERE ANY ERRONEOUS RESULTS REPORTED PRIOR TO GRAM STAIN? NO THERE WAS NO ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787146 ↗
• MalfunctionJan 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS THE BOTTLES ARE FLAGGED AS POSITIVE. GRAM STAIN SHOWS NEGATIVE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11223711 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K915796. One submission often covers many models, so check the product and lot details in each record.

• Z-0236-2026 · Sep 23, 2025 · Open, Classified
  BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Cat
• Z-0594-2025 · Oct 31, 2024 · Open, Classified
  BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
• Z-0593-2025 · Oct 31, 2024 · Open, Classified
  BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
• Z-0596-2025 · Oct 31, 2024 · Open, Classified
  BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
• Z-0869-2014 · Dec 9, 2013 · Terminated
  BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic
• Z-0870-2014 · Dec 9, 2013 · Terminated
  BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of