BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials 442265Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382904422653), received between Feb 22, 2021 and Aug 26, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025False Positive Result; False Positive Result

  REPORT 1 OF 4: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS, ONE FALSE POSITIVE OF C. TROPICALIS OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894462 ↗
• MalfunctionAug 26, 2025False Positive Result; False Positive Result

  REPORT 2 OF 4: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS, ONE FALSE POSITIVE OF C. TROPICALIS OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894433 ↗
• MalfunctionAug 26, 2025False Positive Result; False Positive Result

  REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS, ONE FALSE POSITIVE OF C. TROPICALIS OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894431 ↗
• MalfunctionAug 26, 2025False Positive Result; False Positive Result

  REPORT 3 OF 4: IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS, ONE FALSE POSITIVE OF C. TROPICALIS OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894428 ↗
• MalfunctionApr 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS ONE BACTEC BOTTLE BROKE, 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 21744934 ↗
• MalfunctionMar 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING AN UNSPECIFIED BD BACTEC ANAEROBIC CULTURE VIAL (GLASS) ONE 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 21652710 ↗
• MalfunctionDec 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS BLOOD LEAKED FROM ONE BOTTLE IN THE BACTEC FX INSTRUMENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844406 ↗
• MalfunctionFeb 18, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS PRODUCED 37 FALSE POSITIVES IN DRAWER A, AND 27 FALSE POSITIVES IN DRAWER D AN HOUR AFTER BEING TURNED OFF FOR 10 MINUTES. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVES AN HOUR AFTER TURNING BACK ON AFTER RACK RESEATED IN BOTTOM STACK ALL WERE ANAEROBIC MEDIA TYPE 37 FALSE POSITIVES IN DRAWER A INSTRUMENT T10044 27 FALSE POSITIVES IN DRAWER D INSTRUMENT FB8823" "INSTRUMENTS CHECKED OUT NORMAL PROBLEMS FOUND BUT HAVE DISCOVERED THE ANAEROBIC MEDIA TYPE HAS POSSIBLY BEEN THE CULPRIT TRIGGERED BY DROP IN TEMP WHILE INSTRUMENT OFF FOR 10 MINUTES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562065 ↗
• MalfunctionNov 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE TESTING WITH BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS MULTIPLE BOTTLES WERE LEAKING. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORT OF MULTIPLE BOTTLES LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771772 ↗
• MalfunctionAug 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS 28 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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 CUSTOMER COMPLAINS ABOUT A HIGH NUMBER OF FALSE POSITIVE BLOOD CULTURE BOTTLES ON HIS FX 400 SOLUTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292033 ↗
• MalfunctionMay 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS 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: " SHORT DESCRIPTION REPORT OF FALSE POSITIVES WITH LYTIC ANAEROBIC BLOOD CULTURE BOTTLES DETAILED INCIDENT DESCRIPTION WE ARE OBSERVING FALSE POSITIVES ON BLOOD CULTURE BOTTLES REF (B)(4), EXPIRY DATE 31/08/2021. SOME DETECTIONS ARE VERY EARLY FROM 1 HOUR OF INCUBATION, INTERNAL COMMENTS NO PATIENT IMPACT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807040 ↗
• MalfunctionMay 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS 2 FALSE POSITIVE RESULTS WERE OBTAINED 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: "BLOOD CULTURE BOTTLES FLAGGED POSITIVE BUT NO BACTERIA SEEN ON THE SMEAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787138 ↗
• MalfunctionFeb 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING BIOFIRE TESTING WITH BD BACTEC¿; LYTIC/10 ANAEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED FOR PSEUDOMONAS. 2 RESULTS WERE REPORTED OUT AND 2 PATIENTS WERE TREATED BASED OF RESULTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11363251 ↗