BD BACTEC™ Plus Anaerobic/F Culture Vials 442193Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382904421939), received between Jul 22, 2018 and Jan 12, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS, A VIAL CONTAINING A PATIENT SAMPLE BROKE INSIDE THE BACTEC DEVICE. NO IMPACT TO THE PATIENT OR CUSTOMER WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOTTLE CONTAINED PATIENT SAMPLE FLUID WAS CONTAINED WITHIN THE INSTRUMENT. REVIEWED, PENDING ADDITIONAL INFORMATION IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A BROKEN BOTTLE IN DRAWER A. CUSTOMER PROBLEM: CUSTOMER IS REPORTING A BROKEN BOTTLE IN DRAWER A THE BOTTLE BROKE AS THE ATTEMPTED TO CLOSE DRAWER. THE CLEANED UP SPILL AND NO ONE WAS HURT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237579 ↗
• MalfunctionOct 28, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS 6 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: "IT WAS REPORTED THAT THERE ARE FALSE POSITIVES. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712538 ↗
• MalfunctionAug 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS 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: " I RATHER BELIEVE THIS IS A VIAL SPECIFIC BOTTLE ISSUE, CONSUMABLE ISSUE. MAYBE SOMETHING IS WRONG WITH THE DYE SENSOR AT THE BOTTOM OF THIS BOTTLE. IF GRAM STAINING WAS NEGATIVE, BUT 2 BACTEC FX MEASUREMENT CYCLES SHOW A FALSE POSITIVE RESULT, SOMETHING MUST BE WRONG WITH THAT CONSUMABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292028 ↗
• MalfunctionJun 16, 2021False Positive Result; False Positive Result

  IT WAS REPORTED WHILE USING BD BACTEC" PLUS ANAEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY SUBCULTURE WAS PERFORMED. RESULTS WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RANDOMLY SOME BOTTLES ARE GIVING FALSE POSITIVE IN ANAEROBIC MEDIA. HOW WERE THE RESULTS DETERMINED TO BE ERRONEOUS - FALSE POSITIVE? ANS : INSTRUMENT SHOWING POSITIVE AFTER SUBCULTURE GROWTH WAS NOT GROWN ON MEDIA . WERE ANY ERRONEOUS RESULTS REPORTED? ANS: NO . IF SO - WAS ANY TREATMENT CHANGED DUE TO THE ERRONEOUS RESULTS REPORTED? ANS: NO . DO YOU HAVE PLOTS AVAILABLE? ANS: NO , I WILL ARRANGE BUT IT TAKES LITTLE TIME. WHAT IS THE INSTRUMENT SERIAL NUMBER? NEED TO CHECK . WHAT IS THE SOFTWARE VERSION OF THE INSTRUMENT? LATEST VERSION NEED TO CHECK AND CONFIRM. HAS AN ENGINEER INVESTIGATED THE INSTRUMENT FOR ANY PROBLEMS? NO INSTRUMENT LOG ACTIVITY HAS CHECKED. ARE ALL THE FALSE POSITIVE SAMPLES FROM ONE INSTRUMENT? YES . ARE ALL THE FALSE POSITIVE SAMPLES FROM ONE DRAWER? FX 200 RANDOMLY CAME ON SPECIFIC MEDIA BOTTLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009499 ↗
• MalfunctionFeb 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A FALSE POSITIVE MAY LEAD TO TREATMENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE PATIENT CONSEQUENCE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11267404 ↗
• InjuryJul 22, 2018Break

  IT WAS REPORTED THAT WHILE HANDLING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS, A GLASS VIAL BROKE IN THE USER'S HAND CAUSING BLOOD TO SPLASH OUT OF THE VIAL AND A MINOR CUT ON THE CUSTOMERS HAND WHICH RESULTED IN EXPOSURE TO COLLECTED BLOOD FROM THE VIAL.

  Patient problems: Exposure to Body Fluids; Injury

  MAUDE report 7709434 ↗