Capture-R Ready-ID Extend II 0006457Recalls & 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 of this product is 2 x 8 strips which contain test wells coated with D-negative red cell membranes of 14 group O single donors. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888234000693), received between Mar 2, 2017 and Oct 29, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Negative 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 Negative Result4
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> 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 9252125 ↗MalfunctionApr 6, 2018False Negative Result; False Negative Result
ON 13MAR2018, IT WAS RETROSPECTIVELY DETERMINED THAT A COMPONENT OF A (B)(6) CUSTOMER SITE REPORT FROM (B)(6) 2017, MADE BY AN IMMUCOR EMPLOYEE WHEN THAT EMPLOYEE HAPPENED TO BE VISITING THE CUSTOMER SITE, WHICH WAS PREVIOUSLY REPORTED UNDER (B)(4) REQUIRED AN ADDITIONAL REPORT FOR AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WITH CAPTURE-R READY-ID EXTEND II WHEN TESTED WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7403078 ↗MalfunctionMay 17, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND II WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6572774 ↗MalfunctionMar 2, 2017False Negative Result
ON (B)(6) 2017, IT WAS DETERMINED THAT A CUSTOMER SITE HAD AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND II WHEN USED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6371823 ↗
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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