Capture-R Ready-ID Extend II 0006456Recalls & reported problems
Immucor, Inc. · Capture-R Ready-ID Extend II is intended for use in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. The double-strip configuration is composed of 2 x 8 strips which contain test wells coated with D-negative red blood cell membranes of 14 group O single donors.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234000686), received between Aug 16, 2019 and Apr 30, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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 Result3
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TWO (2) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID EXTENDED II REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ANTIBODY ON ONE (1) OCCASION AND ANTI-D ON ONE (1) OCCASION. 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 10016392 ↗MalfunctionJan 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID EXTENDED II REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ON ONE (1) OCCASION. 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 9647799 ↗MalfunctionAug 16, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WITH CAPTURE-R READ-ID EXTEND II ON THE GALILEO ECHO V2.0 INSTRUMENT.
Patient problems: No Patient Involvement
MAUDE report 8901047 ↗
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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