Anti-M (Murine Monoclonal) Gamma-clone 0004802Recalls & reported problems
Immucor, Inc. · This reagent is intended for the detection of the M antigen on red blood cells by tube test.
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 10888234000464), received between Oct 30, 2017 and Oct 30, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (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
- False Positive Result1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2017False Positive Result
ON 03OCT2017, IT WAS DETERMINED THAT A (B)(6) CUSTOMER REPORT RECEIVED ON 11SEP2017 OF AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-M (MURINE MONOCLONAL) GAMMA-CLONE BY MANUAL TEST TUBE METHOD, WAS REPORTABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6988138 ↗
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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