BD BACTEC™ Myco/F Lytic Culture Vials 442288Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382904422882), received between Jul 8, 2022 and Nov 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025False Negative Result; False Negative Result

  IT WAS REPORTED WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THERE WAS ONE FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465559 ↗
• MalfunctionMar 20, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS, A FALSE NEGATIVE RESULT WAS OBTAINED WHEN TESTING THE BONE MARROW OF A PATIENT KNOWN TO HAVE DISSEMINATED TB. CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON IF THERE WAS PATIENT IMPACT OR ANY CHANGE IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939747 ↗
• MalfunctionJul 8, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THEY SHOWED FALSE NEGATIVES FOR HIV. THIS IS A REPORT OF TWO OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING A QUERY OR POTENTIALLY AN ISSUE IDENTIFIED WITH USE OF THE MYCO F LYTIC BOTTLE 442288 FOR A HIV POSITIVE PATIENT. ESSENTIALLY THE PATIENT SAMPLE HAD ONE BOTTLE REMOVED IN ERROR EARLIER THAN THE PROTOCOL (42 DAYS) AS NEGATIVE AND THE SECOND BOTTLE WAS THEN REMOVED @ 43.5 DAYS ALSO AS NEGATIVE. BECAUSE ONE BOTTLE HAD BEEN REMOVED EARLY THEY DID A TERMINAL AURAMINE TEST AND IT WAS POSITIVE. THEY SENT THE SAMPLES TO ST. JAMES HOSPITAL DUBLIN AND WHILE INTERMITTENT FOR WHATEVER PRIMARY TEST METHOD USED I BELIEVE, ST. JAMES EVENTUALLY REPORTED BOTH BOTTLES AS POSITIVE FOR MYCOBACTERIUM GENAVENSE (M. GENAVENSE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962289 ↗