BD BBL™ Coagulase Plasma, Rabbit with EDTA 240826Recalls & reported problems
Becton, Dickinson And Company · BD BBL™ Coagulase Plasma, Rabbit with EDTA · 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 30382902408261), received between Dec 1, 2021 and Dec 1, 2021 — 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.
MalfunctionDec 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE TESTING WITH BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTA A PERFORMANCE ISSUE RESULTING IN AUTO-AGGLUTINATION OCCURRED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: D. AT WHAT TEMPERATURE WAS THE PRODUCT SHIPPED TO YOU? ¿ ROOM TEMPERATURE HOW DID YOU STORE RECONSTITUTED PLASMA? ¿ USING DEIONIZED WATER IS THIS ISSUE OCCURRING WITH PLASMA FROM BOTH LOTS? - YES C. CUSTOMER PROBLEM: COAG PLASMA 240826 AUTO-AGGLUTINATION PHOTOS OR RETURNS REQUESTED? 1 PHOTO IS ATTACHED, REQUESTED PHOTOS OF AFFECTED PRODUCT WITH LOT NUMBER IT WAS REPORTED THAT COAG PLASMA 240826 AUTO-AGGLUTINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12913619 ↗
Other PLASMA, COAGULASE, HUMAN, HORSE AND RABBIT devices
- BD BBL™ Coagulase Plasma, Rabbit with EDTA 240827Becton, Dickinson And Company · PLASMA, COAGULASE, HUMAN, HORSE AND RABBIT1 report
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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