BD BBL™ TB Fluorescent Stain Kit T 212521Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ TB Fluorescent Stain Kit T Contains: 1 each, TB Auramine-Rhodamine T 250 mL, TB Decolorizer 250 mL, TB Potassium Permanganate 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382902125211), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD BBL TB FLUORESCENT STAIN KIT T THERE WAS PRESENCE OF PRECIPITATE. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE LAST 2 SUPERVISIONS BY THE SOUTH-EAST METROPOLITAN SERVICE (YEARS 2022 AND 2023), IN CONJUNCTION WITH THE PEEC REPORTS, OBSERVATIONS HAVE BEEN MADE REGARDING THE PRESENCE OF PRECIPITATES IN OUR BACILLOSCOPIES. THE OCCURRENCE OF SAID INTERFERENT VARIES FROM RARE TO REGULAR.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 17561206 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page