Anti-K (Monoclonal) Gamma-clone 0066451Recalls & reported problems
Immucor, Inc. · This reagent is used for the detection of the K antigen 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
- 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 10888234001393), received between Apr 4, 2016 and Jan 7, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (4 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 Result4
- False Negative Result1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2019False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-K (MONOCLONAL) GAMMA-CLONE BY GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224272 ↗MalfunctionJan 7, 2019False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-K (MONOCLONAL) GAMMA-CLONE BY GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224256 ↗MalfunctionJan 7, 2019False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-K (MONOCLONAL) GAMMA-CLONE BY GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224115 ↗MalfunctionNov 13, 2017False Positive Result
ON (B)(6) 2017, A CUSTOMER REPORTED SOME UNEXPECTEDLY POSITIVE RESULTS WHEN USING ANTI-K (MONOCLONAL) GAMMA-CLONE BY GALILEO ECHO INSTRUMENT METHOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7025795 ↗MalfunctionApr 4, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING GAMMA-CLONE ANTI-K (MONOCLONAL) WITH GALILEO NEO TESTING METHODOLOGY, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5545849 ↗
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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