BD BBL™ Gram Safranin 212531Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Gram Safranin, 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30382902125311), received between Jun 21, 2023 and Jan 23, 2026 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM SAFRANIN, 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 24168080 ↗MalfunctionJan 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM SAFRANIN, 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 24168079 ↗MalfunctionAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM SAFRANIN 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 22915278 ↗MalfunctionJun 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE WITH THE BD BBL¿ GRAM SAFRANIN, FOUR FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED 4 BLOOD CULTURES THAT WERE REPORTED AS GRAM POSITIVE RODS BUT SHOULD HAVE BEEN GRAM NEGATIVE RODS. GRAM STAINS PERFORMED MANUALLY. OCCURS "MOST OFTEN IN POSITIVE BLOOD CULTURE SMEARS BUT HAVE NOTICED INCONSISTENCIES IN OTHER CULTURE TYPES, IE: URINE, SPUTUM". RESULTS DETERMINED TO BE DISCREPANT BY GNR GROWING IN CULTURE AND ID ON PHOENIX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17173610 ↗
Other STAINS, MICROBIOLOGIC devices
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- 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 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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