BD BACTEC™ FX Bottom 441386Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00382904413866), received between Jan 28, 2021 and Nov 20, 2025 — classified as 99 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (45 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025False Negative Result; False Negative Result

  IT WAS REPORTED WHILE USING BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED THERE WERE FOUR FALSE NEGATIVE RESULTS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604700 ↗
• MalfunctionMar 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED ONE BACTEC BOTTLE BROKE INSIDE THE INSTRUMENT, CAUSING BLOOD/SAMPLE TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653515 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED ONE BACTEC BOTTLE BROKE INSIDE THE INSTRUMENT, CAUSING BLOOD/SAMPLE TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406504 ↗
• MalfunctionFeb 13, 2025False Negative Result; False Negative Result

  REPORT 2 OF 2. IT WAS REPORTED AFTER USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED THERE WAS ONE FALSE NEGATIVE RESULT FROM ONE PATIENT. SUBCULTURE CONFIRMED THE GROWTH OF STREPTOCOCCI. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378936 ↗
• MalfunctionFeb 13, 2025False Negative Result; False Negative Result

  REPORT 1 OF 2. IT WAS REPORTED AFTER USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED THERE WAS ONE FALSE NEGATIVE RESULT FROM ONE PATIENT. SUBCULTURE CONFIRMED THE GROWTH OF STREPTOCOCCI. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378935 ↗
• MalfunctionApr 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED THE CUSTOMER INDICATED A BROKEN VIAL WAS IN THE INSTRUMENT. THE CUSTOMER WAS CAUTIONED TO USE PPE WHEN REMOVING THE VIAL, AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169931 ↗
• MalfunctionMar 10, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED RIGHT FRONT FOOT OF THE FX IS BENT AT A 33 DEGREES. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RIGHT FRONT FOOT OF THE FX IS BENT AT A 33 DEGREES AND WILL NOT MOVE UP OR DOWN. INSTRUMENT IS RUNNING CURRENTLY WITH NO NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521037 ↗
• MalfunctionMar 9, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED THAT THERE WAS FALSE NEGATIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS FALSE NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513253 ↗
• MalfunctionDec 27, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED RIGHT FRONT LEVELING FOOT DISLODGED FROM STRUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FRONT RIGHT LEVELING FOOT BROKEN OFF OF STRUT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056776 ↗
• MalfunctionOct 11, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED HAD THE LEFT FOOT BROKEN. THE RIVET WHICH HOLDS THE FEET STRIPPED OFF THE BASE OF THE STRUT. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE CHARLIE LAU (SR. FSE) WAS ON-SITE FOR (REF: WO-02648164 AND WO-02648195), FSE NOTICED THE LEFT FOOT OF THE BOTTOM BACTEC FX BROKEN; THE RIVET WHICH HOLDS THE FEET STRIPPED OFF THE BASE OF THE STRUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580586 ↗
• MalfunctionOct 4, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED IT WAS FOUND THAT THE FEET WERE BROKEN. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ATTEMPTED TO PERFORM PM AND FOUND THAT FEET WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540385 ↗
• MalfunctionSep 29, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED VIAL BROKE ACCIDENTLY WHILE TRAINING WAS ON-GOING, AND BLOOD GOT SPILLED OVER THE RACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER VIAL BROKE ACCIDENTLY WHILE TRAINING WAS ON-GOING, AND BLOOD GOT SPILLED OVER THE RACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503697 ↗
• MalfunctionJul 14, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED DEVICE, A FALSE NEGATIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TEST. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE NEGATIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019744 ↗
• MalfunctionJul 8, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED LEFT FOOT CANNOT BE ADJUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNOT ADJUST LEFT FOOT. FOUND ON PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960798 ↗
• MalfunctionJun 15, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED HAS WORN FEET. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE CONDUCTING ANNUAL PM, WAS UNABLE TO ADJUST FEET PROPERLY DUE TO WEAR ON ADJUSTMENT NUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707514 ↗
• MalfunctionJun 6, 2022False Positive Result; False Positive Result

  IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED. THIS OCCURRED 10 TIMES. CONFIRMATORY TESTING WAS PERFORMED USING GRAM STAINING. 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: THE SPECIMENS IN QUESTION WERE ALL ORIGINALLY PROCESSED IN OTHER DRAWERS OF THE INSTRUMENT WITH THE SPECIMENS BEING LOADED INTO DRAWER C AND HAVING THEIR PROTOCOL LENGTH CHANGED TO TEN DAYS. NO INSTRUMENT ISSUE FOUND. ISSUE RESOLVED. S/N: (B)(4). CUSTOMER PROBLEM: (B)(6) CALLED TO REPORT HAVING MULTIPLE POSITIVES FROM DRAWER C OF THIS FX INSTRUMENT. (B)(6) INDICATED THEY HAD THREE SPECIMENS THAT FLAGGED AS POSITIVE AT OR NEAR THE SAME TIME THAT ALL SHOWED NO GROWTH WHEN CONFIRMED WITH GRAM STAIN. (B)(6) INDICATED THAT THEY WERE DIFFERENT BOTTLE TYPES. "VIALS AFFECTED (FOR BLOOD CULTURE ONLY)?" Y, TEN. DRAWER C MULTIPLE POSITIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604689 ↗
• MalfunctionJun 2, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT FALSE POSITIVE RESULTS WERE OBTAINED USING THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED AFTER RACK REPLACEMENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE INSTRUMENT HAD DISPLAYED FALSE POSITIVES SHORTLY AFTER RACK REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575948 ↗
• MalfunctionMay 31, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE IN USE THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED PRODUCED 10 FALSE POSITIVES. THIS IS A SINGLE EVENT WITH 10 OCCURRENCES. NP FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT IN DRAWER C , THERE ARE 10 FALSE POSITIVES. THE CUSTOMER HAS ALREADY DONE ALL THE TROUBLESHOOTING RECOMMENDED BY THE USER¿S MANUAL. DRAWER C IF INSTRUMENT HAS BEEN EMPTIED OF VIALS AND TAPED OFF. THERE HAVE BEEN SEVERAL ALERTS IN MULTIPLE ROWS OF MEASUREMENT FAILURES. AN FSE NEEDS TO TROUBLESHOOT WHAT ERROR IS OCCURRING WITH THE MALFUNCTIONING DRAWER. YES, THE ORIGINAL ERROR OCCURRED BECAUSE THE CUSTOMER PULLED OFF 10+ BOTTLES AFTER THE INSTRUMENT ALERTED, SHE GRAM STAINED AND SUBCULTURED THE BOTTLES THAT RANG OFF POSITIVE, NO ORGANISMS WERE SEEN AND THE BOTTLES WERE LOADED IN ANOTHER DRAWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14553681 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  IT WAS REPORTED BY THE CUSTOMER THAT DRAWER D FALSE POSITIVES. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTING FALSE POSITIVES ON DRAWER D WITH NO SPECIFICS ROWS. THE TECH WALKED THEM THROUGH GETTING THE LOGS FOR A REVIEW. THEY REFUSED SAYING THEY ARE TOO BUSY. THEY ASKED THE TECH TO CALL BACK AND WALK HIM THROUGH GETTING THAT LOGS. UNABLE TO REACH THEM . THE TECH LEFT A VM. EMAILED THEM THE STEPS TO GET THE LOGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525047 ↗
• MalfunctionMay 16, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED FALSE POSITIVE RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A FALSE POSITIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413945 ↗
• MalfunctionMay 13, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED FALSE POSITIVE RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT DRAWER C HAD FALSE POSITIVES. 2 FALSE POSITIVES. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SUB CULTURE, NO CONFIRMED POSITIVES. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NO. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402713 ↗
• MalfunctionMay 13, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED FALSE POSITIVE RESULTS WERE ACQUIRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT DRAWER D E1 HAD A FALSE POSITIVE. FALSE POSITIVE WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SUB CULTURE, NO CONFIRMED POSITIVES. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NO. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402688 ↗
• MalfunctionMay 4, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED, FALSE POSITIVE RESULTS WERE ACQUIRED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX441386 / DRAWER C ROWS J/K UNUSABLE. CUSTOMER HAD THIS ISSUE WITH DRAWER C ROWS J/K GOING UNUSABLE. THEY MOVED THE VIALS IN THESE ROWS RIGHT AWAY, BUT SHORTLY AFTER THEY MOVED THE VIALS 4 TURNED POSITIVE SHORTLY AFTER. 3 AEROB BOTTLES AND 1 ANAEROB. CUSTOMER DID A GRAM STAIN AND FOUND NO GROWTH. THEY REINSERTED THE VIALS TO COMPLETE THE PROTOCOL. THESE FALSE POSITIVE RESULTS WERE NOT REPORTED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272876 ↗
• MalfunctionApr 22, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED PRODUCED A FALSE POSITIVE ON THE ANAEROBIC BOTTLE WITH NO GROWTH. A GRAM STAIN WAS PERFORMED AND THE BOTTLE WAS RETURNED TO THE INSTRUMENT, BUT THE RESULTS WERE NOT PROVIDED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS HAVING ANAEROBIC BOTTLES GO POSITIVE WITH NO GROWTH (FALSE POSITIVE)" "THE BOTTLES HAVE BEEN GRAM STAINED AND PUT BACK ONTO THE INSTRUMENT. CUSTOMER STATED THAT FALSE POSITIVES WERE ANAEROBIC BOTTLES FROM LOT #1294783."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187838 ↗
• MalfunctionApr 21, 2022False Positive Result; False Positive Result

  IT HAS BEEN REPORTED THAT THE BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING 4-6 ANAEROBIC 442021 BOTTLES THAT ARE FALSE POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14178011 ↗

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