BD BBL™ Gram Decolorizer 212527Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Gram Decolorizer, 250 mL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382902125274), received between Apr 13, 2022 and Nov 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Ingredient or Reagent Problem1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING THE BD BBL¿ GRAM DECOLORIZER THE USER NOTED A BOTTLE DID NOT HAVE A LABEL AND COULD NOT BE USED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695402 ↗MalfunctionApr 13, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHILE USING BD BBL¿ GRAM DECOLORIZER THE SLIDES WERE OVERSTRIPPED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED USING GRAM STAIN KIT FOR CONTAMINATION CHECKS OF INCOMING MICRO SAMPLES AS PART OF OUR STANDARD PROCESS. DURING THESE CHECKS I HAVE RUN INTO A CONSISTENT ISSUE WITH THE GRAM DECOLORIZER PROVIDED WITH YOUR KIT. MY SLIDES APPEAR TO ALWAYS BE OVER STRIPPED OF CRYSTAL VIOLET. MY PROCEDURE IS AS FOLLOWS FLOOD WITH CRYSTAL VIOLET, ALLOW TO STAND 1 MINUTE, RINSE THOROUGHLY WITH DI WATER, FLOOD WITH GRAM IODINE, ALLOW TO STAND 1 MINUTE, RINSE THOROUGHLY WITH DI WATER, APPLY 1-2 DROPS OF GRAM DECOLORIZER, IMMEDIATELY RINSE THOROUGHLY WITH DI WATER, FLOOD SLIDE WITH SAFRANIN, ALLOW TO STAND 30 SECONDS, RINSE THOROUGHLY WITH DI WATER. DRY IN BOOK OF BIBULOUS PAPER BEFORE MICROSCOPICALLY OBSERVING RESULTS. I WAS WONDERING IF THERE WERE ANY SUGGESTIONS TO PREVENT THE OVER STRIPPING OF THE CRYSTAL VIOLET WITH THE DECOLORIZER? THIS HAS BEEN A CONSISTENT PROBLEM EVEN WITH CONTROL MICROBES SUCH AS B. AGRI AND B. SUBTILIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14108002 ↗
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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