BD BACTEC™ Plus Aerobic/F Culture Vials 442192Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382904421922), received between Feb 2, 2021 and Sep 21, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS HAD LABEL DISCREPANCIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE AGEMED AGENCY INFORMS THE GENERAL POPULATION THAT, THROUGH SPECIAL INSPECTIONS CARRIED OUT, IT HAS BECOME AWARE OF THE COMMERCIALIZATION OF THE BD BACTEC PEDS PLUS/F CULTURE VIALS (PLASTIC) 40ML AND BD BACTEC PLUS AEROBIC/F CULTURE VIALS 30ML REAGENTS WITH LABEL ADULTERATED IN THE PLACE WHERE IT DECLARES THE LOT AND EXPIRATION DATE, THEREFORE, AGEMED DOES NOT GUARANTEE COMPLIANCE WITH THE CRITERIA OF QUALITY, SAFETY AND/OR EFFECTIVENESS OF THE REAGENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786836 ↗
• MalfunctionMay 4, 2022False Positive Result; False Positive Result

  IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL HAS BEEN FOUND GIVING MOLECULAR FALSE POSITIVES. PCR METHODOLOGY WAS USED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THIS CASE SEEMS TO BE A MOLECULAR FALSE POSITIVE. THE CUSTOMER DID CONFIRM THAT THE CONFIRMATORY TEST METHOD, WHILE ANONYMOUS, WAS A PCR METHODOLOGY USED. CUSTOMER PROBLEM: CUSTOMER IS REPORTING FALSE POSITIVES - 442192, LOT 1251310 AND 1286477.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274792 ↗
• MalfunctionJan 28, 2022False Positive Result; False Positive Result

  IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS HAS BEEN FOUND PRODUCING FALSE POSITIVE RESULTS. SUB-CULTURING WAS PERFORMED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE MICROBIAL GROWTH TEST (ALL VIALS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389083 ↗
• MalfunctionNov 1, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL, A MOLECULAR FALSE POSITIVE USING A BACTEC MEDIA WAS OBTAINED BY THE LABORATORY PERSONNEL. CONFIRMATORY GRAM TESTING WAS PERFORMED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT ACINETOBACT. RESULT FROM A POSITIVE BACTEC BC DISCREPANT ACINETOBACTER-BAUMANNII RESULT. GRAM STAIN: GRAM-POSITIVE COCCI BUT NO GRAM-NEGATIVE BACTERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729366 ↗
• MalfunctionOct 28, 2021Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL, LEAKING OF A PATIENT SAMPLE AND FALSE POSITIVE RESULT WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BACTEC BOTTLE LEAKING. POSITIVE BOTTLE. CUSTOMER WAS ABLE TO SAFELY OBTAIN A GRAMSTAIN AND SUBCULTURE FROM THE BOTTLE AND CONFIRMED THAT THE BOTTLE WAS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712643 ↗
• MalfunctionOct 7, 2021False Positive Result; False Positive Result

  IT WAS REPORTED WITH TESTING PATIENT SAMPLES WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS USING THE BIOFIRE 4 SAMPLES DETECTED ACINETOBACTER. CULTURES DID NOT GROW OUT ACINETOBATER. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BACTEC SAMPLES WITH DISCREPANT RESULTS USING BIOFIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591604 ↗
• MalfunctionOct 6, 2021Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC" PLUS AEROBIC/F CULTURE VIAL, BIOLOGICAL CONTAMINATION WAS IDENTIFIED AND FALSE POSITIVE RESULTS WERE OBTAINED USING PCR TESTING BY THE LABORATORY PERSONNEL. THE BIOFIRE IS RESULTING AS ACINETOBACTER AS WELL AS ANOTHER ORGANISM BUT THE ACINETOBACTER DOES NOT GROW. THE CUSTOMER STATED ONE OF THE THREE PATIENT'S RESULTS WAS REPORTED OUT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR BIOFIRE IS RESULTING AS ACINETOBACTER BAUMANII AND ANOTHER ORGANISM FROM 442192 BOTTLES. THE ACINETOBACTER DOES NOT GROW IN CULTURE. ONE OF THE PATIENTS DID HAVE THE ACINETOBACTER REPORTED OUT. AFTER IT DID NOT GROW IN CULTURE THEY HAD TO GO BACK AND CALL THE ORGANISM NON-VIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586397 ↗
• MalfunctionOct 6, 2021Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL, BIOLOGICAL CONTAMINATION WAS IDENTIFIED AND FALSE POSITIVE RESULTS WERE OBTAINED USING PCR TESTING BY THE LABORATORY PERSONNEL. THE BIOFIRE IS RESULTING AS ACINETOBACTER AS WELL AS ANOTHER ORGANISM BUT THE ACINETOBACTER DOES NOT GROW. THE CUSTOMER STATED ONE OF THE THREE PATIENT'S RESULTS WAS REPORTED OUT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR BIOFIRE IS RESULTING AS ACINETOBACTER BAUMANII AND ANOTHER ORGANISM FROM (B)(4) BOTTLES. THE ACINETOBACTER DOES NOT GROW IN CULTURE. ONE OF THE PATIENTS DID HAVE THE ACINETOBACTER REPORTED OUT. AFTER IT DID NOT GROW IN CULTURE THEY HAD TO GO BACK AND CALL THE ORGANISM NON-VIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586393 ↗
• MalfunctionOct 6, 2021Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL, BIOLOGICAL CONTAMINATION WAS IDENTIFIED AND FALSE POSITIVE RESULTS WERE OBTAINED USING PCR TESTING BY THE LABORATORY PERSONNEL. THE BIOFIRE IS RESULTING AS ACINETOBACTER AS WELL AS ANOTHER ORGANISM BUT THE ACINETOBACTER DOES NOT GROW. THE CUSTOMER STATED ONE OF THE THREE PATIENT'S RESULTS WAS REPORTED OUT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR BIOFIRE IS RESULTING AS ACINETOBACTER BAUMANII AND ANOTHER ORGANISM FROM 442192 BOTTLES. THE ACINETOBACTER DOES NOT GROW IN CULTURE. ONE OF THE PATIENTS DID HAVE THE ACINETOBACTER REPORTED OUT. AFTER IT DID NOT GROW IN CULTURE THEY HAD TO GO BACK AND CALL THE ORGANISM NON-VIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586383 ↗
• MalfunctionAug 10, 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 GRAM STAIN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "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 12304477 ↗
• MalfunctionJun 15, 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 100 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A SUBCULTURE WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RANDOMLY SOME BOTTLES ARE GIVING FALSE POSITIVE RESULTS WHEN DO SUBCULTURE IT WAS NO GROWTH ON MEDIA . ADDITIONAL INFORMATION FROM TASK: WERE ANY ERRONEOUS RESULTS REPORTED? ANS: NO IF SO - WAS ANY TREATMENT CHANGED DUE TO THE ERRONEOUS RESULTS REPORTED? ANS : NO "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005360 ↗
• MalfunctionMay 6, 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 2 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: "BLOOD CULTURE BOTTLES FLAGGED POSITIVE BUT NO BACTERIA SEEN ON THE SMEAR. PLEASE VERIFY IF THERE WAS ANY PATIENT IMPACT - WERE ANY ERRONEOUS RESULTS REPORTED PRIOR TO GRAM STAIN? NO THERE WAS NO ERRONEOUS RESULTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787112 ↗
• MalfunctionApr 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS A BROKEN BOTTLE THAT LEAKED SAMPLE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN AEROBIC BLOOD CULTURE BOTTLE BROKE DURING TRANSPORT FROM THE HOSPITAL WARD TO THE LABORATORY. AT THE AWARENESS DAY THE CUSTOMER NO LONGER HAD THE LOT NUMBER AVAILABLE AS THE BOTTLE HAD BEEN ALREADY DISPOSED OF IN SPECIAL WASTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644922 ↗
• 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 11267260 ↗