Capture-R Ready-ID Extend I 0006454Recalls & reported problems
Immucor, Inc. · Capture-R Ready-ID Extend I 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-positive red cell membranes of 14 group O single donors.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888234000662), received between Apr 12, 2018 and Jul 30, 2020 — classified as 11 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (11 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 Result11
Patient problems
- No Known Impact Or Consequence To Patient10
- Test Result1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING THE CAPTURE-R READY ID EXTEND I 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 A POSITIVE RESULT AS EXPECTED FOR THE ANTI-FYA ANTIBODY 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 10345933 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID EXTEND I 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 MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-S ANTIBODY ON ONE (1) OCCASION; THE ANTI-CW ANTIBODY ON ONE (1) OCCASION AND THE ANTI-K ANTIBODY 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 10016386 ↗MalfunctionJan 29, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID EXTENDED I 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 MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ON TWO (2) OCCASIONS AND THE ANTI-CW ANTIBODY 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: Test Result
MAUDE report 9645072 ↗MalfunctionJun 10, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8683370 ↗MalfunctionApr 4, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8484201 ↗MalfunctionMar 19, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8434279 ↗MalfunctionJan 15, 2019False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID EXTEND I ON AN ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8247428 ↗MalfunctionJan 14, 2019False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID EXTEND I ON AN ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8245589 ↗MalfunctionOct 1, 2018False Negative Result; False Negative Result
ON 06SEP2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7924270 ↗MalfunctionSep 5, 2018False Negative Result; False Negative Result
ON 09AUG2018, AN IMMUCOR EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SITE AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7847822 ↗MalfunctionApr 12, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7426445 ↗
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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