Anti-IgG,-C3d (Polyspecific) (Murine Monoclonal) (Uncolored) Gamma-clone 0401010Recalls & reported problems
Immucor, Inc. · This product is used in direct or indirect antiglobulin tests where the detection of IgG or C3 (as C3b or C3d) is required. This product contains a blend of murine monoclonal antibodies directed at the relevant human proteins, in proportions designed to achieve optimum proportions of anti-IgG, anti-C3d and anti-C3b. The package configuration for this product code is ten (10) vials of reagent. The color of the liquid reagent is clear.
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 10888234001638), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative 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 Negative Result1
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.
MalfunctionNov 6, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER RECEIVED UNEXPECTED (B)(6) REACTIONS WITH ANTI-IGG, C3D.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10805618 ↗
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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