Capture-R Ready Indicator Red Cells 0006428Recalls & reported problems
Immucor, Inc. · This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration. · Class 2
All models of Capture-R Ready Indicator Red Cells (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Immucor Capture-R Ready Indicator Red Cells product is a lab quality control kit of coated red cells used to check blood banking assays for antibodies. The 52 reports mostly describe patient samples testing negative for antibodies that other methods showed were present, in some cases contributing to a delayed hemolytic transfusion reaction. No deaths and no injuries are described. There are no recalls naming 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
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10888234000600), received between Jul 19, 2016 and Jul 30, 2020 — classified as 52 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (49 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 Result49
- Incorrect, Inadequate or Imprecise Result or Readings2
- Incorrect Or Inadequate Test Results1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient26
- No Consequences Or Impact To Patient21
- No Code Available2
- No Information1
- Patient Problem/Medical Problem1
- Test Result1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOUR (4) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY INDICATOR CELLS 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 RESULTS PRODUCED FALSE NEGATIVES BASED ON EXPECTATIONS FOR THE ANTI-E ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-E 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: Test Result
MAUDE report 10346483 ↗MalfunctionJan 3, 2020False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9548822 ↗MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY INDICATOR CELLS 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 ONE (1) OCCASION; THE ANTI-CW ANTIBODY ON ONE (1) OCCASION AND THE ANTI-D 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 9252073 ↗MalfunctionJul 19, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8808940 ↗MalfunctionApr 26, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR A SCREEN ASSAY ON A GALILEO ECHO V2 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8558105 ↗MalfunctionApr 23, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS FOR A CROSSMATCH ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8540049 ↗MalfunctionJan 18, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON AN ECHO LUMENA INSTRUMENT, WHEN TESTED ON (B)(6) 2018, WHICH LED TO AN EVENT BEING CATEGORIZED AS A DELAYED HEMOLYTIC TRANSFUSION REACTION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8261112 ↗MalfunctionDec 5, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8135344 ↗MalfunctionDec 3, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8126233 ↗MalfunctionNov 1, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED TO IMMUCOR TECHNICAL SUPPORT, ON BEHALF OF A CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8029563 ↗MalfunctionSep 13, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7874323 ↗MalfunctionMay 29, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7550727 ↗MalfunctionMay 25, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7545105 ↗MalfunctionMay 14, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7510968 ↗MalfunctionApr 19, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7443133 ↗MalfunctionApr 19, 2018False Negative Result; False Negative Result
ON 27MAR2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7443111 ↗MalfunctionApr 17, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE COMPATIBLE CROSSMATCH WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7437925 ↗MalfunctionApr 9, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, IT WAS DETERMINED THAT A CUSTOMER SITE COMPLAINT REPORTED ON (B)(6) 2018 WAS DEEMED TO BE REPORTABLE BECAUSE OF AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEEN AND IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY GALILEO ECHO METHOD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7407563 ↗MalfunctionMar 26, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY CROSSMATCH WHEN USING CAPTURE-R READY INDICATOR RED CELLS BY MANUAL CAPTURE METHOD, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7371568 ↗MalfunctionMar 13, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7335507 ↗MalfunctionFeb 14, 2018False Negative Result; False Negative Result
ON 19JAN "2017", A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7270265 ↗MalfunctionFeb 13, 2018False Negative Result; False Negative Result
ON 19JAN "2017", A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7268364 ↗MalfunctionFeb 2, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7235327 ↗MalfunctionJan 15, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7192047 ↗MalfunctionDec 19, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7131025 ↗
Other Kit, Quality Control For Blood Banking Reagents devices
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- ALBAcyte C3 Coated Red Blood Cells Z482UAlba Bioscience Limited · Kit, Quality Control For Blood Banking Reagents2 reports
- IH-Internal QC 814172100Bio-Rad Medical Diagnostics GmbH · Kit, Quality Control For Blood Banking Reagents1 report
- VIROTROL 00101FBio-Rad Laboratories, Inc. · KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS1 report
- VIROTROL 00100ABio-Rad Laboratories, Inc. · KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS1 report
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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