BD BBL™ TB Auramine M 212514Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ TB Auramine M, 4 x 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30382902125144), received between Sep 30, 2021 and Apr 16, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
- Contamination of Device Ingredient or Reagent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TB AURAMINE M BOTTLE, THERE WAS PRECIPITATION PRESENT IN THE STAIN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896733 ↗MalfunctionApr 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ TB AURAMINE M BOTTLE, THERE WAS PRECIPITATION PRESENT IN THE STAIN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896189 ↗MalfunctionAug 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED BEFORE USE OF BD BBL TB AURAMINE M, PRECIPITATION/YELLOW PIGMENT WAS OBSERVED AT THE BOTTOM OF THE BOTTLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19975506 ↗MalfunctionOct 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ TB AURAMINE M 4 BOTTLES WERE DISCOVERED TO HAVE PRECIPITATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTED PRECIPITATES IN THE BOTTLES OF TB AURAMINE M STAIN THEY RECEIVED FROM LOT 1089351, EXP: 2022-04-30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12632733 ↗MalfunctionSep 30, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT THE BOTTLE TB AURAMINE M 250ML EXPERIENCED BIOLOGICAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED SEDIMENTS/PRECIPITATES IN THEIR BOTTLE OF TB AURAMINE M STAIN FROM LOT 0288107, EXP: 2021-10-31 (CAT# 212514). THEY ARE USING THE TB FLUORESCENT STAIN KIT M FOR THE MORSE COLORATION. SHE DIDN¿T PROVIDE THE STAIN KIT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12558067 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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