BD BACTEC™ Standard/10 Aerobic/F Culture Vials 442027Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 30382904420278), received between Mar 16, 2021 and Nov 14, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE FOR C. TROPICALIS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS EXPERIENCING MOLECULAR FALSE POSITIVES FOR C. TROPICALIS ON BIOFIRE BCID2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132289 ↗
• MalfunctionOct 16, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE FOR C. TROPICALIS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS EXPERIENCING MOLECULAR FALSE POSITIVES FOR C. TROPICALIS ON BIOFIRE BCID2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940870 ↗
• MalfunctionAug 23, 2023False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE FALSE NEGATIVE RESULTS OF THREE SAMPLES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE NEGATIVE RESULT. THE NEGATIVE SAMPLE WAS SENT TO A SUPPORT LABORATORY, WHICH FOUND POSITIVITY IN THE SLIDE AND GROWTH IN THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604223 ↗
• MalfunctionJun 6, 2022False Positive Result; False Positive Result

  IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED. 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: CUSTOMER REPORTS THAT HE OBTAINED A FALSE POSITIVE RESULT ON AN APHERESIS BAG DURING A BACTEC FX EQUIPMENT VERIFICATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604635 ↗
• MalfunctionSep 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED A FALSE POSITIVE ACINETOBACTER RESULT WHEN NO GNR SEEN IN THE GRAM STAIN. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: POSITIVE BLOOD CULTURE BOTTLE THAT BIOFIRE IDENTIFIED AS AN ACINETOBACTER WHERE THERE WAS NO GNR SEEN IN THE GRAM STAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537450 ↗
• MalfunctionAug 25, 2021Contamination; False Positive Result; Contamination; False Positive Result

  IT WAS REPORTED THAT 19 BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) WERE CONTAMINATED AND FALSE POSITIVE RESULTS FOR PAENIBACILLUS URINALS WERE OBTAINED. CUSTOMER STATED THAT THE PATIENT MOST LIKELY WERE TREATED FOR THE ORGANISM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONFIRM THIS INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION IN 442027 BOTTLE WITH PAENIBACILLUS URINALIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368285 ↗
• MalfunctionAug 25, 2021Contamination; Incorrect, Inadequate or Imprecise Result or Readings; Contamination; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT 4 BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) WERE CONTAMINATED AND FALSE POSITIVE RESULTS FOR PAENIBACILLUS URINALIS WERE OBTAINED. CUSTOMER STATED THAT THE PATIENT MOST LIKELY WERE TREATED FOR THE ORGANISM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONFIRM THIS INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION IN 442027 BOTTLE WITH PAENIBACILLUS URINALIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368284 ↗
• MalfunctionAug 25, 2021Contamination; False Positive Result; Contamination; False Positive Result

  IT WAS REPORTED THAT 7 BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) WERE CONTAMINATED AND FALSE POSITIVE RESULTS FOR PAENIBACILLUS URINALIS WERE OBTAINED. CUSTOMER STATED THAT THE PATIENT MOST LIKELY WERE TREATED FOR THE ORGANISM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONFIRM THIS INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION IN 442027 BOTTLE WITH PAENIBACILLUS URINALIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368283 ↗
• MalfunctionAug 25, 2021Contamination; False Positive Result; Contamination; False Positive Result

  IT WAS REPORTED THAT 2 BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) WERE CONTAMINATED AND FALSE POSITIVE RESULTS FOR PAENIBACILLUS URINALIS WERE OBTAINED. CUSTOMER STATED THAT THE PATIENT MOST LIKELY WERE TREATED FOR THE ORGANISM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONFIRM THIS INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS CONTAMINATION IN 442027 BOTTLE WITH PAENIBACILLUS URINALIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368278 ↗
• MalfunctionAug 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS 10 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A DIFFERENTIAL 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: "BLOOD PLATE TRANSFER WAS PERFORMED ON THE SPECIMENS IN THE BOTTLE PLASTIC BACTEC LYTIC/10 ANAER/F REPORTING FALSE POSITIVE, NO BACTERIAL GROWTH WAS OBSERVED AFTER 48 HOURS OF CULTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322110 ↗
• MalfunctionJun 25, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT WHILE USING 3 BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) A MISSING LABEL AND A PHYSICAL DEFECT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LACK OF LABEL, THE CULTURE BOTTLE IS OUT OF SHAPE, BARCODE NUMBER ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12067949 ↗
• MalfunctionMar 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490570 ↗