BD BBL™ TB Stain Kit K 212522Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00382902125228), received between Sep 24, 2024 and Sep 5, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2025Class IIOpen, Classified

   One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

   Z-1296-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977589 ↗
• MalfunctionSep 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951753 ↗
• MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948624 ↗
• MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948620 ↗
• MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948602 ↗
• MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948600 ↗
• MalfunctionJul 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USE OF BD BBL¿ TB STAIN KIT K, A KIT COMPONENT (TB CARBOLFUCSHIN) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576011 ↗
• MalfunctionJul 23, 2025Expiration Date Error; Expiration Date Error

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K, A KIT COMPONENT (TB CARBOLFUCSHIN) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575278 ↗
• MalfunctionApr 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING ONE (1) BD BBL¿ TB STAIN KIT K THAT THE PRODUCT WAS LABELED WITH AN EXPIRATION DATE OF 30-SEP-2024 BUT REALLY EXPIRED ON 30-APR-2025. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926121 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE BOTTLE OF TB CARBOLFUSHIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876785 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE BOTTLE OF TB CARBOLFUSHIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876782 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE BOTTLE OF TB CARBOLFUSHIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876215 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE BOTTLE OF TB CARBOLFUSHIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876214 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BEFORE USING BD BBL¿ TB STAIN KIT K, ONE (1) COMPONENT BOTTLE OF TB CARBOL FUSHIN STAIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876212 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE KIT HAD A TB CARBOLFUCHSIN BOTTLE WITH AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876211 ↗
• MalfunctionApr 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE KIT HAD A TB CARBOLFUCHSIN BOTTLE WITH AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876209 ↗
• MalfunctionApr 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD BBL¿ TB STAIN KIT K THAT ONE BOTTLE OF TB CARBOLFUSHIN HAD AN EXPIRATION DATE PRIOR TO THE KIT EXPIRATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868788 ↗
• MalfunctionNov 26, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED PRIOR TO USE OF 3 BD BBL¿ TB STAIN KIT K KITS, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777401 ↗
• MalfunctionNov 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USE OF BD BBL¿ TB STAIN KIT K, A KIT COMPONENT (TB CARBOLFUCSHIN) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE FOUND IN 2 KITS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722909 ↗
• MalfunctionNov 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USE OF ONE BD BBL¿ TB STAIN KIT K, A KIT COMPONENT HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694028 ↗
• MalfunctionNov 7, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED IN THREE (3) BD BBL¿ TB STAIN KIT K, A KIT COMPONENT(TB CARBOLFUCSHIN ) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630346 ↗
• MalfunctionOct 30, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED IN THREE (3) BD BBL¿ TB STAIN KIT K, A KIT COMPONENT(TB CARBOLFUCSHIN ) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566992 ↗
• MalfunctionOct 30, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USE OF ONE BD BBL¿ TB STAIN KIT K, A KIT COMPONENT(TB CARBOLFUCSHIN ) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566989 ↗
• MalfunctionOct 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USE OF BD BBL¿ TB STAIN KIT K, 1 BOTTLE IN THE KIT HAD NO LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559193 ↗
• MalfunctionOct 21, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED PRIOR TO USE OF ONE BD BBL¿ TB STAIN KIT K, A KIT COMPONENT(TB CARBOLFUCSHIN) HAD AN EXPIRATION DATE PRIOR TO KIT EXPIRATION DATE. IN ADDITION, THE CERTIFICATE OF ANALYSIS LOT NUMBER FOR TB CARBOLFUCSHIN DOES NOT MATCH THE LOT # RECEIVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500880 ↗