Anti-D (Monoclonal Blend) Gamma-clone 0066420Recalls & reported problems
Immucor, Inc. · This reagent is intended for use in slide, tube and microplate tests, for the detection of the Rh (D) antigen.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888234001348), received between Apr 13, 2018 and Apr 21, 2020 — classified as 5 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
- Device Damaged Prior to Use1
- False Positive Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2020False Negative Result; False Negative Result
PRODUCT NOTIFICATION ISSUED 04/16/2020 FOR GAMMA-CLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT, LOTS 506300, 506301 REGARDING DECREASE IN PRODUCT POTENCY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9981711 ↗MalfunctionApr 21, 2020False Negative Result; False Negative Result
PRODUCT NOTIFICATION ISSUED 04/16/2020 FOR GAMMA-CLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT, LOTS 506300, 506301 REGARDING DECREASE IN PRODUCT POTENCY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9981687 ↗MalfunctionOct 11, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
ON (B)(6) 2019 A CUSTOMER REPORTED THAT THEY CUT THEIR FINGER ON BROKEN VIAL OF ANTI-D (MONOCLONAL BLEND).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9180410 ↗MalfunctionMay 20, 2019False Positive Result; False Positive Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED POSITIVE REACTION WITH GAMMACLONE ANTI-D (MONOCLONAL BLEND).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8625324 ↗MalfunctionApr 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) GAMMA-CLONE BY MANUAL TEST TUBE METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7428890 ↗
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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