BD BBL™ Cooked Meat Medium 221508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382902215081), received between Nov 9, 2021 and Nov 9, 2021 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 9, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING ON BD BBL¿ COOKED MEAT MEDIUM OBTAINED A FALSE POSITIVE RESULT . THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO PATIENT IMPACT. CONFIRMATORY PCR TESTING WAS PERFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS USING THE INOCULATED COOKED MEAT MEDIUM TO ENHANCE THE GROWTH OF CLOSTRIDIUM PERFRINGENS AND CLOSTRIDIUM BOTULINUM. AFTERWARDS THEY SUBCULTURE THE COOKED MEAT MEDIUM ONTO TRYPTOSE GLUCOSE YEAST AGAR. TO CONFIRM THE PRESENCE OF CLOSTRIDIUM PERFRINGENS , THEY PERFORM A PCR TEST TO DETECT CPA GEN = ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS. FOR QUALITY PURPOSE THEY ALSO PERFORM A PCR TEST FROM AN UNINOCULATED COOKED MEAT MEDIUM TUBE (WITHOUT SAMPLE) AND FOUND OUT THAT THE MEDIUM ITSELF CONTAIN A HIGH DOSE OF ALPHA TOXIN GEN OF CLOSTRIDIUM PERFRINGENS, RESULTING IN FALSE POSITIVE PCR RESULTS. THEREFORE CUSTOMER CONSIDER THE COOKED MEAT MEDIUM TUBES CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783680 ↗