BD BACTEC™ Standard/10 Aerobic/F Culture Vials 442260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904422608), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN TEST 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: " - NUMBER OF WRONG RESULTS OBTAINED: 3."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575537 ↗