Anti-Fyb (Monoclonal) Gamma-clone 0004818Recalls & reported problems
Immucor, Inc. · Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234002383), received between Apr 30, 2020 and Jul 9, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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.
Most reported problems
Device problems
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2021False Negative Result; False Negative Result
ON JUNE 4, 2021 A CUSTOMER RECEIVED UNEXPECTED NEGATIVE RESULTS WITH FYB ASSAY ON THE MANUAL PLATFORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12146794 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF AN EVENT INDICATED THAT DURING A REAGENT VALIDATION TEST USING ANTI-FYB GAMMA-CLONE (MONOCLONAL) REAGENT PRODUCED A NEGATIVE RESULT FOR THE ANTI-FYB ANTIBODY VERSUS A POSITIVE RESULT FOR ANTI-FYB POLYCLONAL. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10016372 ↗
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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