BD BBL™ TB Decolorizer 212517Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ TB Decolorizer, 250 mL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30382902125175), received between Jan 7, 2025 and Feb 19, 2025 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ TB DECOLORIZER, ONE (1) PATIENT SAMPLE CONTAINED BRANCHING ORGANISMS THAT WAS STAINING KINYOUN POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411153 ↗MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 3 OF 3: IT WAS REPORTED WHILE USING BD BBL¿ TB DECOLORIZER, NOCARDIA STAINED AS FULL ACID FAST ON A PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21098694 ↗MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 2 OF 3: IT WAS REPORTED WHILE USING BD BBL¿ TB DECOLORIZER, NOCARDIA STAINED AS FULL ACID FAST ON A PATIENT SAMPLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21098693 ↗MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
REPORT 1 OF 3: IT WAS REPORTED WHILE USING BD BBL¿ TB DECOLORIZER, NOCARDIA STAINED AS FULL ACID FAST ON A PATIENT SAMPLE. A PRELIMINARY RESULT WAS REPORTED AS AN ACID FAST ORGANISM, AND THEN UPON FURTHER REVIEW RESULTS WERE CORRECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21098658 ↗
Other Stains, microbiologic devices
- BD BBL™ TB Stain Kit K 212522Becton, Dickinson And Company · STAINS, MICROBIOLOGIC1 recall29 reports
- BD BBL™ TB Fluorescent Stain Kit M 212519Becton, Dickinson And Company · STAINS, MICROBIOLOGIC68 reports
- PREVI® Color Gram RB IODINE solution 29586Biomerieux SA · Stains, microbiologic1 recall0 reports
- BD BBL™ India Ink Reagent Droppers 261194Becton, Dickinson And Company · STAINS, MICROBIOLOGIC13 reports
- BD BBL™ Gram Crystal Violet 212525Becton, Dickinson And Company · Stains, microbiologic8 reports
- BD BBL™ Gram Stain Kit 212539Becton, Dickinson And Company · STAINS, MICROBIOLOGIC7 reports
- BD BBL™ Gram Safranin 212531Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
- BD BBL™ Gram Iodine (Stabilized) 212542Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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