BD BACTEC™ FX40 Instrument 442296Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00382904422967), received between Feb 26, 2020 and Sep 30, 2026 — classified as 1 death, 66 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (25 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 18, 2026.

Recalls naming this device

1. Sep 23, 2025Class IIOpen, 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, 2024Class IIOpen, 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-0594-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950941 ↗
• MalfunctionSep 9, 2026False Negative Result

  It was reported while using BD BACTEC¿ FX40 Instrument there was one false negative result. No adverse impact was reported regarding the patient or user at this time.This is report 2 of 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690922 ↗
• MalfunctionSep 8, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676775 ↗
• MalfunctionAug 4, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131796 ↗
• MalfunctionFeb 5, 2026False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT, THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271816 ↗
• MalfunctionFeb 5, 2026False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT, THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271692 ↗
• MalfunctionJan 28, 2026False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT, THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199983 ↗
• MalfunctionJan 28, 2026False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT, THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199980 ↗
• MalfunctionDec 16, 2025False Negative Result; False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818621 ↗
• MalfunctionSep 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX40 INSTRUMENT THERE WAS A MIS ASSOCIATION OF ONE PATIENT SAMPLE NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994491 ↗
• MalfunctionJul 28, 2025Fire; Fire

  IT WAS REPORTED WHILE USING THE BD BACTEC¿ FX40 INSTRUMENT, THE UPS CAUGHT FIRE. THERE WERE NO INJURIES OR DAMAGE TO STRUCTURES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631276 ↗
• MalfunctionMar 22, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHEN USING THE BD BACTEC¿ FX40 INSTRUMENT, THERE WERE FREQUENT FALSE NEGATIVES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958392 ↗
• MalfunctionMar 15, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ FX40 INSTRUMENT, THERE WERE TWO ANAEROBIC BOTTLES FOR THE SAME PATIENT RESULTED IN FALSE NEGATIVE. NO PATIENT TREATMENT WAS IMPACTED AS RESULTS WERE CORROBORATED BY AEROBIC CULTURE BOTTLES AND TREATMENT WAS BASED ON THOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911494 ↗
• MalfunctionFeb 15, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX40 INSTRUMENT, THERE WAS A FALSE NEGATIVE RESULT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711623 ↗
• MalfunctionJan 17, 2024False Negative Result; False Negative Result

  IT WAS REPORTED WHEN USING THE BD BACTEC¿ FX40 INSTRUMENT THAT THERE WAS A FALSE NEGATIVE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18529783 ↗
• MalfunctionMay 17, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD BACTEC¿ FX40 INSTRUMENT FALSE NEGATIVES ARE BEING REPORTED EVEN WITH GRAM STAIN WITH A HUGE AMOUNT OF GRAM NEGATIVE BACILI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT REPORTS THAT AFTER THE END OF THE 5-DAY PROTOCOL INCUBATION, WHEN THE BOTTLE COMES OUT WITH A NEGATIVE RESULT, WHEN PERFORMING THE GRAM TEST, BGN ARE VISUALIZED. FALSE NEGATIVE, EVEN WITH THE GRAM STAIN WITH A HUGE AMOUNT OF GRAM NEGATIVE BACILLI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948415 ↗
• MalfunctionApr 26, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX40 INSTRUMENT THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS FALSE NEGATIVE RESULT. THE CLIENT REPORTS THAT AFTER THE END OF THE 5-DAY PROTOCOL INCUBATION, WHEN THE BOTTLE COMES OUT WITH A NEGATIVE RESULT, WHEN PERFORMING THE GRAM TEST, BGN ARE VISUALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820397 ↗
• MalfunctionDec 10, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD BACTEC¿ FX40 INSTRUMENT FALSE NEGATIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPECIES: CANINE. SAMPLE VOLUME: 2.5ML (PEDIATRIC VIAL - PEDS PLUS/F CULTURE VIALS (PLASTIC). IT IS THE VOLUME. USED IN THE VAST MAJORITY OF OUR PATIENTS AND WE HAVE NEVER HAD THIS PROBLEM. SAMPLE COLLECTED ON 7/11 AND PLACED IN BACTEC ON 8/11 (POSITION A9). ON 11/14 THE BOTTLE CAME OUT OF THE EQUIPMENT AS A NEGATIVE SAMPLE. WHEN WE DID THE GRAM STAIN, IT WAS FULL OF GRAM NEGATIVE RODS. PLATE SEEDING WAS PERFORMED AND, IN FACT, GRAM-NEGATIVE BACTERIA GREW. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956062 ↗
• MalfunctionSep 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS FALSE NEGATIVE ON BD BACTEC¿ FX40 INSTRUMENT. GRAM STAIN WAS PERFORMED TO CONFIRM. NO PATIENT IMPACT WAS REPORTED THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE CUSTOMER WISHES TO UNDERSTAND A CURVE FOR A BOTTLE: A BACTEC BOTTLE (N° 449278015834) WAS SENT POS TO THE SIL BUT THE BACTEC APPEARS AS NEG ON THE CURVE REPORT. ITS CURVE IS CLEARLY A POS CURVE. THE CLIENT INFORMS ME THAT THEY DID A SUBCULTURE AND GRAM STAIN WHICH SHOWED THE PRESENCE OF BACTERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415441 ↗
• MalfunctionJul 15, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD BACTEC¿ FX40 INSTRUMENT THERE WERE FALSE NEGATIVES THAT OCCURRED. THIS IS A REPORT OF A SINGLE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPAIR ORDER FROM CUSTOMER AS APPARENTLY NEGATIVE RESULTS WERE REPORTED WHERE GROWTH CURVE WOULD BE POSITIVE. NEW VALUE: INFO FROM APPS SPECIALIST WILFRED AFTER LOGS AND DATABASE ANALYSIS: TO CONCLUDE; THERE IS NOTHING TO POINT TO AN ISSUE WITH THE BACTEC ¿ THE ONE PATIENT THAT IS IN THE LOGS FLAGGED NEGATIVE ON BOTH BOTTLES AND THE CURVE SUGGESTS INDEED AS YOU POINT OUT THAT THEY ARE JUST LOOKING AT LEUKOCYTE METABOLISM (FOR WHICH THE ALGORITHMS CORRECT). THE CUSTOMER SHOULD LEARN TO TREAT SEPARATE BOTTLES OF ONE PATIENT AS SEPARATE BOTTLES AND HAVE FAITH IN THE SYSTEM TO FLAG WHEN IT IS DONE CASE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033513 ↗
• MalfunctionJun 29, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE THE BD BACTEC¿ FX40 INSTRUMENT POOR GROWTH CURVES WERE OBSERVED, WHICH RESULTED IN FALSE NEGATIVES. THIS IS A REPORT OF A SINGLE OCCURRENCE. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. FALSE RESULTS WERE DUE TO USER ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEMS WITH GROWTH CURVE - GROWTH STOPS. RECOMMENDATIONS TO THE CLIENT WERE PROVIDED WO-02344592. RECOMMENDATIONS WERE GIVEN FOR THE INOCULATED VIALS TO BE INTRODUCED INTO THE EQUIPMENT DURING THE TWO HOURS FOLLOWING THE SAMPLING, SINCE THE FALSE NEGATIVES OCCURRED BECAUSE THE VIALS WERE ENTERED MORE THAN 6 HOURS AFTER THE SAMPLE HAD BEEN TAKEN,PROBLEM WAS USER ERROR THAT WAS SOLVED AFTER THIS RECOMMENDATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14862303 ↗
• MalfunctionJun 23, 2022Patient Data Problem; Patient Data Problem

  IT WAS REPORTED THAT WHILE USING THE CUSTOMER BD BACTEC¿ FX40 INSTRUMENT THE CUSTOMER ASSIGNED THE WRONG ACCESS NUMBER TO TWO BOTTLES FROM DIFFERENT PATIENTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CORRECTION OF PATIENT DATA AND REASSIGNMENT OF BLOOD CULTURE BOTTLE", "THE CHEMIST CONFUSED THE ACCESS NUMBERS AND WRONGLY REGISTERED THE BOTTLES, SHE INVERTED THE BOTTLES WITH THE PATIENTS, SHE WAS HELPED IN THE CORRECTION PROCESS AND THE PROBLEM WAS SOLVED. NO IMPACT FOR THE PATIENTS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14794206 ↗
• MalfunctionJun 14, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX40 INSTRUMENT THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. ERRONEOUS RESULTS WERE CONFIRMED VIA GRAM STAINING. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTS FALSE POSITIVE RESULTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14688659 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ FX40 INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO CASES OF FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526538 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ FX40 INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO CASES OF FALSE POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526390 ↗

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-0593-2025 · Oct 31, 2024 · Open, Classified
  BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
• 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