BD BBL™ Gram Crystal Violet 212525Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Gram Crystal Violet · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30382902125250), received between Oct 11, 2024 and Jan 26, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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 Readings8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ GRAM CRYSTAL VIOLET, THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183423 ↗MalfunctionAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916531 ↗MalfunctionAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22915789 ↗MalfunctionAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22915311 ↗MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE BOTTLE OF BD BBL¿ GRAM CRYSTAL VIOLET, THERE WAS FALSE POSITIVE GRAM STAIN RESULTS DUE TO STAINING PRECIPITATE LEFT OVER ON THE SLIDES. NO PATIENT OR USER IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771284 ↗InjuryJul 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. ONE (1) PATIENT HAD ERRONEOUS RESULTS OF GRAM-POSITIVE COCCI REPORTED AND WAS ADMINISTERED VANCOMYCIN. THE RESULT WAS SUBSEQUENTLY CORRECTED IN THE PATIENT'S CHART. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORTED VERBATIM, "HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DETAILED ERRONEOUS RESULTS: FALSELY REPORTED GRAM POSITIVE COCCI BEING SEEN ON THE GRAM STAIN SLIDE. WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS: PATIENT WAS TREATED WITH VANCOMYCIN. CUSTOMER IS UNSURE AT THIS MOMENT IF THEY WILL BE CHANGING TREATMENT FROM THE VANCOMYCIN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22575300 ↗MalfunctionMay 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT ONE (1) KIT CONTAINED ARTIFACTS THAT RESEMBLED GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060891 ↗MalfunctionOct 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. ONE (1) PATIENT HAD ERRONEOUS RESULTS OF GRAM-POSITIVE COCCI REPORTED AND WAS ADMINISTERED VANCOMYCIN. THE RESULT WAS SUBSEQUENTLY CORRECTED IN THE PATIENT'S CHART. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORTED VERBATIM, "HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DETAILED ERRONEOUS RESULTS: FALSELY REPORTED GRAM-POSITIVE COCCI BEING SEEN ON THE GRAM STAIN SLIDE. WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS: PATIENT WAS TREATED WITH VANCOMYCIN. CUSTOMER IS UNSURE AT THIS MOMENT IF THEY WILL BE CHANGING TREATMENT FROM THE VANCOMYCIN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20432416 ↗
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 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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