Anti-A (Murine Monoclonal) Series 1 0006400Recalls & reported problems
Immucor, Inc. · Anti-A (Murine Monoclonal) Series 1 is intended for use in slide, tube, microplate and automated tests, for the detection of the A antigen.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888234000525), received between Jul 9, 2016 and Jan 30, 2020 — classified as 12 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (9 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 Result9
- False Positive Result2
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient4
- Test Result1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THIS REPORT SUMMARIZES MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING ANTI-A MURINE MONOCLONAL SERIES 1 ANTISERA ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED A FORWARD ABO MISTYPE. THE RESULT REPRESENTED AN ABO/RH MISTYPE BY PRODUCING A RESULT THAT THE PATIENT WAS A-, WHEN IN FACT SUBSEQUENT TESTING AND PRIOR TESTING SHOWED THE PATIENT WAS O- DUE TO TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED A DIFFERENT ABO/RH PHENOTYPE. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.
Patient problems: Test Result
MAUDE report 9650204 ↗MalfunctionOct 31, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE INSTRUMENT RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 BY GALILEO NEO, WHICH LED TO AN ABO MISTYPE ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8025974 ↗MalfunctionJul 26, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY (B)(6) MANUAL TEST TUBE RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 BY MANUAL TEST TUBE, WHICH LED TO AN ABO MISTYPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7722475 ↗MalfunctionJan 29, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO ECHO INSTRUMENT, WHICH LED TO AN ABO MISTYPE, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7226085 ↗MalfunctionDec 18, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO ECHO INSTRUMENT, WHICH LED TO AN ABO MISTYPE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7125570 ↗MalfunctionOct 26, 2017False Negative Result
ON 03OCT2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017, WHICH LED TO AN ABO MISTYPE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6979688 ↗MalfunctionAug 15, 2017False Negative Result
ON (B)(4)2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6)2017, WHICH LED TO AN ABO MISTYPE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6795819 ↗MalfunctionAug 15, 2017False Negative Result
ON (B)(6)2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6)2017, WHICH LED TO AN ABO MISTYPE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6795652 ↗MalfunctionMar 30, 2017False Negative Result
ON (B)(6) 2017, IT WAS DETERMINED THAT A CUSTOMER EVENT OF UNEXPECTED NEGATIVE WELL RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO INSTRUMENT WAS TO BE REPORTED. CUSTOMER TESTING OF THE BLOOD SAMPLE IN QUESTION WAS ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6445775 ↗MalfunctionFeb 28, 2017False Negative Result
ON 09FEB2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6366305 ↗MalfunctionFeb 28, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6366024 ↗MalfunctionJul 9, 2016False Negative Result
ON (B)(6) 2016, AN IMMUCOR FIELD SERVICE ENGINEER (FSE), WHILE VISITING A CUSTOMER SITE, REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-A (MURINE MONOCLONAL) SERIES 1 ON A GALILEO NEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5780525 ↗
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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