Anti-D (Monoclonal Blend) Series 4 0006412Recalls & reported problems
Immucor, Inc. · Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888234000556), received between Apr 5, 2016 and Jul 30, 2020 — classified as 16 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (13 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 Result13
- False Negative Result3
- Unexpected Therapeutic Results1
Patient problems
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2020False Positive Result; False Positive Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) POOLED TEST THAT INCLUDED SIX (6) DONOR SAMPLES PRODUCED AN RH MISTYPE WITH A RESULT OF D+ VERSUS A D- KNOWN PHENOTYPE USING THE ANTI-D SERIES 4 REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10347346 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTS HAD AN RH NEGATIVE RESULT USING ANTI-D SERIES 4. TUBE TESTING PROVIDED A RESULT OF RH POSITIVE. NO WEAK D TESTING WAS PERFORMED. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10016360 ↗MalfunctionJan 30, 2020False Positive Result; False Positive Result
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST PRODUCED AN RH MISTYPE RESULTING IN AN A+ TYPING VERSUS AN A- KNOWN PHENOTYPE USING ANTI-D MONOCLONAL BLEND SERIES 4 REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM. ONE (1) PATIENT SAMPLE TEST PRODUCED AN UNEXPECTED POSITIVE RESULT USING ANTI-D MONOCLONAL BLEND SERIES 4 ON AN AUTOMATED BLOOD BANK SYSTEM. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9649547 ↗MalfunctionApr 4, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND BY GALILEO ECHO METHOD, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8484754 ↗MalfunctionDec 4, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND BY ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8130200 ↗MalfunctionOct 1, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND BY GALILEO NEO, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7923548 ↗MalfunctionSep 10, 2018False Positive Result; False Positive Result
ON 17AUG2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND BY MANUAL TEST TUBE METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7860386 ↗MalfunctionSep 10, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND BY MANUAL TEST TUBE METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7860370 ↗MalfunctionJun 25, 2018False Positive Result; False Positive Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7635210 ↗MalfunctionMay 15, 2018False Positive Result; False Positive Result
ON 26APR2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE OUTCOME WITH ANTI-D (SERIES 4) MONOCLONAL BLEND ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7516034 ↗MalfunctionFeb 7, 2018False Positive Result; False Positive Result
A CUSTOMER REPORTED OBTAINING WEAK REACTIONS WHILE PERFORMING RH TYPING ON TWO (2) DONOR UNITS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7248919 ↗MalfunctionMay 5, 2017False Positive Result; Unexpected Therapeutic Results
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) SERIES 4 ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2017 WITH THE WEAK D ASSAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6549256 ↗MalfunctionMar 14, 2017False Positive Result
ON (B)(6) 2017, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) SERIES 4 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6402551 ↗MalfunctionJul 19, 2016False Positive Result
ON (B)(6) 2016 A CUSTOMER REPORTED UNEXPECTED POSITIVE (1+) WEAK D REACTIVITY USING ANTI-D (MONOCLONAL BLEND) SERIES 4 LOT 504705 ON AN RH NEGATIVE PATIENT SAMPLE. NO ADVERSE EVENT OCCURRED DUE TO THE UNEXPECTED RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5805494 ↗MalfunctionJul 6, 2016False Positive Result
ON 0(B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) SERIES 4 ON A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5772204 ↗MalfunctionApr 5, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING ANTI-D (MONOCLONAL BLEND) SERIES 4 ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5548233 ↗
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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