Capture-R Ready-ID 0066214Recalls & reported problems
Immucor, Inc. · Capture-R Ready-ID is used 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. This product is a double-strip configuration which carry the bound and dried membranes prepared from 14 group O donors. Each microplate contains six (6) double-strips, and the plate is sealed in a pouch. 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.
All models of Capture-R Ready-ID (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Immucor Capture-R Ready-ID is a blood bank reagent used to detect unexpected antibodies in a patient's blood. The 38 reports, with no deaths and no injuries, mostly describe tests giving unexpected negative results for antibodies that other methods found present. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10888234001188), received between Jun 2, 2016 and Sep 5, 2025 — classified as 38 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (37 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result37
- False Positive Result1
Patient problems
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient17
- No Clinical Signs, Symptoms or Conditions2
- Test Result1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY ID RESULT FOR CAPTURE-R READY-ID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986519 ↗MalfunctionSep 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY ID RESULT FOR CAPTURE-R READY-ID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986518 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT SIX (6) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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; THE ANTI-K ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-D ON ONE (1) OCCASION AND THE ANTI-KPA 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 10346450 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT EIGHT (8) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED NINE (9) 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 ANTIBODY ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-K ANTIBODY ON ONE (1) OCCASION; THE ANTI-M ANTIBODY ON ONE (1) OCCASION; THE ANTI-FYA ON TWO (2) OCCASIONS AND ANTI-C 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 10016366 ↗MalfunctionJan 29, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FIFTEEN (15) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON NINE (9) OCCASIONS; THE ANTI-K ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-CW ANTIBODY ON ONE (1) OCCASION AND THE ANTI-LUB 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 9644667 ↗MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT SEVEN (7) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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 ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-FYA ANTIBODY 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 FOUR (4) 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 9252080 ↗MalfunctionMay 21, 2019False Positive Result; False Positive Result
ON (B)(6) 2019 A CUSTOMER IN (B)(6) REPORTED UNEXPECTED NEGATIVE RESULTS WITH CAPTURE-R READY-ID ON THE EU VERSION OF GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8628897 ↗MalfunctionJan 22, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID ON AN ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8268760 ↗MalfunctionJan 21, 2019False Negative Result; False Negative Result
ON (B)(4) 2019, A (B)(6) CUSTOMER REPORTED, VIA EMAIL, AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8264389 ↗MalfunctionJan 21, 2019False Negative Result; False Negative Result
ON (B)(4) 2019, A (B)(6) CUSTOMER REPORTED, VIA EMAIL, AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8264381 ↗MalfunctionJan 16, 2019False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY (B)(6) ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8253096 ↗MalfunctionJan 14, 2019False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER REPORTED, VIA EMAIL, AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A NEO IRIS INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8245692 ↗MalfunctionDec 31, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID, WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206417 ↗MalfunctionSep 21, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID, WHEN USED ON AN ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898032 ↗MalfunctionJul 31, 2018False Negative Result; False Negative Result
ON 19JUL2018, IT WAS DETERMINED THAT A EUROPEAN (B)(6) REPORT FROM (B)(6) 2018 WAS REPORTABLE AS AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7736458 ↗MalfunctionMay 31, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED (B)(6) ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7557993 ↗MalfunctionNov 20, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON GALILEO ECHO INSTRUMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7045320 ↗MalfunctionNov 6, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7004049 ↗MalfunctionOct 12, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE REPORTED, ON BEHALF OF THE CUSTOMER SITE, AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6946274 ↗MalfunctionOct 10, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6936482 ↗MalfunctionAug 23, 2017False Negative Result
ON (B)(6) 2017, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED SOME INFORMATION ABOUT AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHICH WAS THEN SUBSEQUENTLY DETERMINED TO BE REPORTABLE ON 02AUG2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6813660 ↗MalfunctionAug 7, 2017False Negative Result
ON (B)(6) 2017 , A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6771612 ↗MalfunctionJul 28, 2017False Negative Result
ON 11JUL2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6751731 ↗MalfunctionFeb 1, 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 WHEN USED ON A GALILEO ECHO INSTRUMENT, SERIAL NUMBER (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292563 ↗MalfunctionNov 15, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON GALILEO ECHO INSTRUMENTS, SERIAL NUMBERS (B)(4), WHEN TESTED ON 27SEP2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6102878 ↗
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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