Anti-D Series 4 (Murine Monoclonal) 0006413Recalls & reported problems
Immucor, Inc. · Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
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 10888234002000), received between Jun 6, 2016 and Feb 26, 2018 — classified as 2 malfunctions.
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
- False Positive Result1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7297353 ↗MalfunctionJun 6, 2016False Positive Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) SERIES 4 ON A GALILEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5702047 ↗
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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