BD BBL™ Gram Iodine (Stabilized) 212542Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Gram Iodine (Stabilized), 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30382902125427), received between Mar 10, 2020 and Jan 28, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 Readings3
- Clumping in Device or Device Ingredient1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Test Result1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM IODINE (STABILIZED), 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. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198537 ↗MalfunctionJan 27, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING ONE (1) BD BBL¿ GRAM IODINE (STABILIZED), 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 24192586 ↗MalfunctionAug 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD BBL¿ GRAM IODINE (STABILIZED) 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 AVAILABLE REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22915318 ↗InjuryMar 10, 2020Signal Artifact/Noise; Clumping in Device or Device Ingredient
THE CUSTOMER REPORTED THAT WHILE USING BD BBL¿ GRAM IODINE (STABILIZED) THEY NOTICED LARGE COCCI LIKE ARTIFACT AND CLUMPING IN THE STAIN. THE ARTIFACT AND CLUMPING OBSCURED THE READING OF A SYNOVIAL GRAM STAIN WHICH LEAD TO ERRONEOUS RESULTS BEING REPORTED BY THE TECHNICIAN. THE TECHNICIAN REPORTED THE ERRONEOUS GRAM STAIN RESULT TO THE CLINICIAN AND THE PATIENT UNDERWENT AN UNNECESSARY SURGICAL PROCEDURE.
Patient problems: Test Result; Therapeutic Effects, Unexpected
MAUDE report 9812223 ↗
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™ 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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