BD BBL™ Acridine Orange Stain 212537Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Acridine Orange Stain, 4 x 250 mL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382902125373), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING BD BBL¿ ACRIDINE ORANGE STAIN HAS PERFORMANCE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDE THE INTIAL REPORTER: RAPID TEST FOR PRESENCE OF MICROORGANISMS (BACTERIA, YEAST, MOLD) LIMITATIONS OF METHOD MULTIPLE STUDIES MENTIONED ACRIDINE ORANGE¿S INABILITY TO DISCRIMINATE BETWEEN A LIVE AND DEAD CELL. SAW POOR CORRELATION BETWEEN THIS METHOD AND INGREDIENTS WHERE THERE WAS A HIGH LEVEL OF NON-VIABLE BACTERIA DUE TO A PROCESS STEP (E.G. BLANCHING OF VEGETABLES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16434405 ↗
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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