Anti-C (Monoclonal) Gamma-clone 0066421Recalls & reported problems
Immucor, Inc. · This reagent is used for the detection of the C antigen (Rhesus blood group system) on red blood cells by tube test. This product configuration is a single vial.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888234001355), received between Jan 3, 2017 and Apr 8, 2021 — classified as 9 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (5 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 Positive Result5
- False Negative Result4
Patient problems
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- Test Result1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2021False Positive Result; False Positive Result
ON MARCH 10, 2021 IMMUCOR BECAME AWARE OF AN EVENT INVOLVING AN UNEXPECTED POSITIVE REACTION FOR A UNIT FROM A DONOR WHO WAS HISTORICALLY NEGATIVE FOR C ANTIGEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11639337 ↗MalfunctionApr 30, 2020False Positive Result; False Positive Result
THIS REPORT SUMMARIZES MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING ANTI-C MONOCLONAL GAMMA CLONE ANTISERA ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED A FALSE POSITIVE RESULT IN MANUAL TUBE. SUBSEQUENT TESTING AND PRIOR TESTING SHOWED THE PATIENT WAS NEGATIVE FOR ANTI-C. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.
Patient problems: Test Result
MAUDE report 10016382 ↗MalfunctionMay 14, 2019False Positive Result; False Positive Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED POSITIVE RESULTS WITH GAMMA-CLONE ANTI-C (MONOCLONAL).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609433 ↗MalfunctionMay 10, 2018False Negative Result; False Negative Result
ON 17APR2018, A (B)(6) CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY GALILEO NEO INSTRUMENT METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7503044 ↗MalfunctionApr 9, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY MANUAL TEST TUBE METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7409112 ↗MalfunctionJan 9, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE AT A CUSTOMER SITE REPORTED, ON BEHALF OF THE CUSTOMER, AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY GALILEO ECHO INSTRUMENT METHOD, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7175530 ↗MalfunctionMar 13, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY GALILEO ECHO INSTRUMENT METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6399214 ↗MalfunctionMar 13, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY GALILEO ECHO INSTRUMENT METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6399073 ↗MalfunctionJan 3, 2017False Positive Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-C (MONOCLONAL) GAMMA-CLONE BY MANUAL METHOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6219178 ↗
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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