BD BBL™ TB Fluorescent Stain Kit M 212519Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ TB Fluorescent Stain Kit M Contains: 1 each, TB Auramine M 250 mL, TB Decolorizer TM 250 mL, TB Potassium Permangante 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD BBL TB Fluorescent Stain Kit is a set of laboratory stains used to look for tuberculosis bacteria under a microscope. Most of the 68 reports describe white sediment or precipitate forming in the stain, which makes the microscopic readings unclear or hard to interpret, along with some reports of contamination and inaccurate results. None describe deaths or injuries. There are no recalls for this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00382902125198), received between May 30, 2024 and Jan 16, 2026 — classified as 68 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (48 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 Readings48
- Contamination20
Patient problems
- No Clinical Signs, Symptoms or Conditions68
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100630 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 5 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100628 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 4 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100627 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 6 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100624 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 6.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100622 ↗MalfunctionJan 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24097118 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939394 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939151 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938786 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938764 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938760 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938753 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938670 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938665 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938632 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938582 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938571 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938552 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938474 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22938462 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932795 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932328 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932323 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932271 ↗MalfunctionSep 2, 2025Contamination; Contamination
IT WAS REPORTED PRIOR TO USING BD BBL¿ TB FLUORESCENT STAIN KIT M, THERE WAS WHITE PRECIPITATE/SEDIMENT IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22932270 ↗
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- BD BBL™ Gram Iodine (Stabilized) 212542Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
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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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