Capture-R Ready-ID Extend I 0006455Recalls & 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 2 x 8 strips containing test wells coated with D-positive red blood 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888234000679), received between Jan 31, 2017 and Oct 29, 2019 — classified as 8 malfunctions.
The most frequently reported specific device problem is “False Negative 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 Negative Result7
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient2
- Patient Problem/Medical Problem1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 3 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-JKA ON ONE (1) OCCASION; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-D ANTIBODY ON ONE (1) OCCASION AND THE ANTI-E ANTIBODY ON TWO (2) OCCASIONS. 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 9252112 ↗MalfunctionAug 5, 2019Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2019, CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR ANTI-FYA USING CAPTURE R EXTEND I ON AN ECHO V 2.0 WITH ONE PATIENT SAMPLE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8862054 ↗MalfunctionApr 24, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WITH CAPTURE-R READY-ID EXTEND I ON AN ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8546161 ↗MalfunctionApr 17, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS USING CAPTURE-R READY-ID EXTEND I ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8523289 ↗MalfunctionFeb 6, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CANADIAN CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7244416 ↗MalfunctionFeb 6, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7244403 ↗MalfunctionJul 7, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID EXTEND I WHEN USED ON TWO (2) GALILEO ECHO INSTRUMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6693443 ↗MalfunctionJan 31, 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 I WHEN USED ON A GALILEO ECHO INSTRUMENT, SERIAL NUMBER (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6290544 ↗
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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