BD BBL™ TB Carbolfuchsin KF 212518Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ TB Carbolfuchsin KF, 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30382902125182), received between Apr 9, 2021 and Jan 7, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 Readings6
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 CARBOLFUCHSIN KF, 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 21098659 ↗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 CARBOLFUCHSIN KF, 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 21098657 ↗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 CARBOLFUCHSIN KF, 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 21098656 ↗MalfunctionFeb 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE TESTING WITH BD BBL¿ TB CARBOLFUCHSIN KF PRECIPITATE AND IMPURITIES WERE FOUND IN THE STAIN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPURITES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13545001 ↗MalfunctionJun 18, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IMPURITIES".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12028646 ↗MalfunctionApr 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF CONTAMINATION PRECIPITATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. "IMPURITY. ON 21MAR2021/(B)(4). UPDATE FROM RCC PROVIDED: THERE IS NO CONTAMINATION. YES, IT IS PRECIPITATE IN THE STAIN. USER FOUND THE PURPLE PARTICLE AFTER LOOKING AT THE MICROSCOPE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11653760 ↗MalfunctionApr 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD BBL¿ TB CARBOLFUCHSIN KF CONTAMINATION PRECIPITATE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IMPURITY: (B)(6) - UPDATE FROM (B)(6) : THERE IS NO CONTAMINATION. YES, IT IS PRECIPITATE IN THE STAIN. YOU CAN ALSO FIND THE PURPLE PARTICLE IN THE MICROSCOPE PHOTO AS (B)(6) ATTACHED. USER FOUND THE PURPLE PARTICLE AFTER LOOKING AT THE MICROSCOPE. PURPLE PARTICLE COVERED THE STAIN RESULTS. IT INCREASES THE ERROR RISK OF CLINICAL REPORT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11644614 ↗
Other CARBOL FUCHSIN devices
- BD BBL™ TB Carbolfuchsin ZN 212511Becton, Dickinson And Company · CARBOL FUCHSIN1 report
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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