BD BBL™ Gram Stain Kit 212539Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Gram Stain Kit, 250 mL · Class 1
Data updated Oct 16, 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 00382902125396), received between Jun 17, 2024 and Apr 2, 2026 — classified as 7 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
- Device Markings/Labelling Problem3
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.
MalfunctionApr 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM STAIN KIT, THERE WAS PRECIPITATE PRESENT ON THE SLIDES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766455 ↗MalfunctionJan 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ GRAM STAIN KIT, THE CUSTOMER NOTICED ABNORMAL STAINING RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020072 ↗MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM STAIN KIT, THERE WAS PRECIPITATE PRESENT AFFECTING THE USER'S ABILITY TO DISTINGUISH PRECIPITATE FROM ORGANISM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002477 ↗MalfunctionMar 21, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL¿ GRAM STAIN KIT THAT ONE (1) CASE WAS MISSING THE PRODUCT LABEL. THE CONTENTS OF THE CASE WERE LABELED APPROPRIATELY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665552 ↗MalfunctionNov 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL¿ GRAM STAIN KIT THAT A COMPONENT WAS MISSING A PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770743 ↗MalfunctionOct 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD BBL GRAM STAIN KIT THAT ONE (1) SAFRANIN RED BOTTLE WAS MISSING THE PRODUCT LABEL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345357 ↗MalfunctionJun 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL GRAM STAIN KIT THAT THERE WAS BACTERIA CONTAMINATION ON THE QUALITY CONTROL SLIDE. THE STAIN DID NOT PASS QUALIFICATION FOR USE AND WAS NOT USED ON PATIENT SAMPLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19548472 ↗
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 Safranin 212531Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
- BD BBL™ Gram Iodine (Stabilized) 212542Becton, Dickinson And Company · STAINS, MICROBIOLOGIC4 reports
- BD BBL™ TB Decolorizer 212517Becton, 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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