Anti-B (Murine Monoclonal) Series 3 0006406Recalls & reported problems
Immucor, Inc. · Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888234000532), received between Sep 14, 2016 and Oct 31, 2018 — classified as 14 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (7 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 Result7
- False Negative Result5
- Adverse Event Without Identified Device or Use Problem1
- Unexpected Therapeutic Results1
Patient problems
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient6
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2018False Positive Result; False Positive Result
ON 06OCT2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8025577 ↗MalfunctionOct 15, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018. THIS LED TO AN ABO MISTYPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7967516 ↗MalfunctionOct 15, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018. THIS LED TO AN ABO MISTYPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7967511 ↗MalfunctionFeb 27, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE OUTCOME WITH ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7301129 ↗MalfunctionAug 15, 2017False Negative Result
ON 29JUL2017, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6795473 ↗MalfunctionJul 7, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6694521 ↗MalfunctionJun 28, 2017False Positive Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6673651 ↗MalfunctionFeb 24, 2017False Positive Result
ON 03FEB2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6357280 ↗MalfunctionFeb 7, 2017Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6307219 ↗MalfunctionJan 4, 2017False Positive Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6221498 ↗MalfunctionJan 3, 2017False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6219373 ↗MalfunctionNov 14, 2016False Positive Result
ON 28OCT2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6100297 ↗MalfunctionNov 14, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6099323 ↗MalfunctionSep 14, 2016Unexpected Therapeutic Results
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-B (MURINE MONOCLONAL) SERIES 3 ON A GALILEO INSTRUMENT.
Patient problems: No Information
MAUDE report 5950941 ↗
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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