BD BACTEC™ FX Top 441385Recalls & reported problems

Summary

The FDA's MAUDE database contains 475 adverse event reports that list this exact device (DI 00382904413859), received between Jan 15, 2019 and Aug 25, 2026 — classified as 1 death, 2 injuries, 472 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (203 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 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 16, 2026.

Recalls naming this device

1. Sep 23, 2025Open, Classified

   Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

   Z-0236-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Oct 31, 2024Open, Classified

   BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

   Z-0593-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 475 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434985 ↗
• MalfunctionJun 4, 2026False Negative Result

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX TOP, THERE WAS A FALSE NEGATIVE PATIENT RESULT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392281 ↗
• MalfunctionMay 20, 2026False Negative Result

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX TOP, THERE WAS A FALSE NEGATIVE PATIENT RESULT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229454 ↗
• MalfunctionMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX TOP, A PATIENT RESULT WAS ASSOCIATED WITH AN INCORRECT PATIENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617045 ↗
• MalfunctionJan 5, 2026Application Network Problem

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, ACCESSION NUMBERS WERE INCORRECTLY ASSIGNED. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957598 ↗
• MalfunctionDec 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, PATIENT SPECIMENS WERE ASSOCIATED WITH THE INCORRECT PATIENTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828910 ↗
• MalfunctionAug 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, THERE WERE TWO (2) FALSE NEGATIVE RESULTS. THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783075 ↗
• MalfunctionAug 4, 2025False Negative Result; False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698880 ↗
• MalfunctionApr 25, 2025False Negative Result; False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913669 ↗
• MalfunctionApr 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX TOP, A CRACKED BOTTLE WAS USED IN THE INSTRUMENT WHICH LED TO INSTRUMENT CONTAMINATION WITH PATIENT SAMPLE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793000 ↗
• MalfunctionMar 25, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, THE INSTRUMENT WAS UNSTABLE WITH A RISK OF IT FALLING OVER. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691571 ↗
• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, A FALSE SPECIMEN ASSOCIATION CAUSED A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667653 ↗
• MalfunctionMar 18, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT FOLLOWING SERVICE ON THE BD BACTEC¿ FX TOP, THE INSTRUMENT WAS UNSTABLE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632981 ↗
• MalfunctionJan 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX TOP, A SAMPLE BOTTLE HAD TO BE FORCIBLY REMOVED. THIS LED TO THE BOTTLE BURSTING, AND THE INSTRUMENT WAS THEN CONTAMINATED WITH PATIENT SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197759 ↗
• MalfunctionJan 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE REMOVING A GLASS SAMPLE BOTTLE FROM THE BD BACTEC¿ FX TOP, THE BOTTLE BROKE CAUSING SAMPLE TO LEAK INTO THE INSTRUMENT. NO REPORT OF ADVERSE IMPACT TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148105 ↗
• MalfunctionNov 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC FX TOP, THE INCORRECT SEQUENCE NUMBER WAS CAPTURED FROM A SCANNED BACTEC BOTTLE. THIS OCCURRED WITH TWO (2) BOTTLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651491 ↗
• MalfunctionSep 4, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED, THERE WAS (1) ONE FALSE NEGATIVE PATIENT RESULT. THE ERRONEOUS RESULT WAS REPORTED TO THE CLINICIAN; HOWEVER, NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. CONFIRMATORY TESTING PERFORMED INCLUDED GRAM STAIN AND CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135882 ↗
• MalfunctionJul 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED, ONE (1) BACTEC BOTTLE BROKE WHILE IT WAS INSERTED INTO THE INSTRUMENT, WHICH CAUSED BLOOD TO LEAK OUT. THE INSIDE OF THE AFFECTED DRAWER WAS DISASSEMBLED AND CLEANED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799660 ↗
• MalfunctionJul 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED, THERE WAS MISASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702101 ↗
• MalfunctionApr 18, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED, FALSE NEGATIVES WERE FOUND. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132686 ↗
• MalfunctionApr 1, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP PACKAGED, A FALSE NEGATIVE RESULT WAS OBTAINED BEFORE THE END OF THE INCUBATION TIME. NO REPORT OF ADVERSE OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015552 ↗
• MalfunctionApr 1, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THAT THERE WAS A FALSE NEGATIVE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010580 ↗
• MalfunctionMar 29, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THERE WAS A FALSE NEGATIVE ON DRAWER B STATION K6. RESULTS WERE NOT REPORTED OUT. NO PATIENT IMPACT. REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006558 ↗
• MalfunctionMar 29, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED THERE WAS A FALSE NEGATIVE ON DRAWER B STATION K6. RESULTS WERE NOT REPORTED OUT. NO PATIENT IMPACT. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006556 ↗
• MalfunctionFeb 20, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED, THERE WAS ONE BLOOD CULTURE RESULTING IN A FALSE NEGATIVE. GRAM STAINING DETECTED CAPNOCYTOPHAGA CANIMORSUS. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740933 ↗

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-0596-2025 · Oct 31, 2024 · Open, Classified
  BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
• Z-0594-2025 · Oct 31, 2024 · Open, Classified
  BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
• 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
• 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