Capture-R Ready-Screen (I and II) 0006440Recalls & reported problems
Immucor, Inc. · Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens. 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-Screen (I and II) (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Immucor Capture-R Ready-Screen is a blood bank reagent used to check patient samples for unexpected antibodies to red blood cells before transfusion. The 33 reports mostly describe screens coming back negative when antibodies were actually present, so some samples needed other testing to confirm. Three reports mention a transfusion reaction in the patient. There are 33 malfunctions, no injuries and no deaths, and no recalls name this product.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10888234000648), received between Apr 13, 2016 and Jul 18, 2023 — classified as 33 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (33 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 Result33
Patient problems
- No Consequences Or Impact To Patient19
- No Known Impact Or Consequence To Patient11
- Transfusion Reaction3
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED THAT THEY HAD RECEIVED A NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THEIR NEO IRIS INSTRUMENT. THE PATIENT RECEIVED A TRANSFUSION, AND A DELAYED SEROLOGICAL REACTION WAS OBSERVED. SUBSEQUENTLY ANTI-C AND ANTI-JKB WERE IDENTIFIED.
Patient problems: Transfusion Reaction
MAUDE report 17347473 ↗MalfunctionMar 21, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY (MISSED ANTI-K) WITH CAPTURE-R READY-SCREEN 3 ON THEIR ECHO LUMENA INSTRUMENT.
Patient problems: Transfusion Reaction
MAUDE report 16587906 ↗MalfunctionMar 7, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY (MISSED ANTI-S) WITH CAPTURE-R READY-SCREEN (I AND II) ON THEIR NEO IRIS INSTRUMENT.
Patient problems: Transfusion Reaction
MAUDE report 16496213 ↗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 TESTS USING THE CAPTURE-R READY SCREEN I & 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-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 10345949 ↗MalfunctionJul 12, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED A CORRELATION DISCREPANCY ON A NEO IRIS INSTRUMENT. ON (B)(6) 2019 ADDITIONAL INFORMATION WAS REPORTED THAT CHARACTERIZED THE EVENT AS UNEXPECTED NEGATIVE SCREENING RESULTS ON A NEO IRIS INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8786792 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 2 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471210 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 2 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471164 ↗MalfunctionDec 3, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT ON (B)(6) 2018 AND (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8126682 ↗MalfunctionJun 28, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7647118 ↗MalfunctionApr 20, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (I AND II) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7448368 ↗MalfunctionMar 22, 2018False Negative Result; False Negative Result
ON 27FEB2018, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7361649 ↗MalfunctionDec 11, 2017False Negative Result
ON 15NOV2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7105444 ↗MalfunctionNov 27, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7061340 ↗MalfunctionNov 27, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7060918 ↗MalfunctionNov 20, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7046850 ↗MalfunctionNov 20, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7046828 ↗MalfunctionNov 13, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE, REPORTED FORTY-THREE (43) HISTORICALLY UNEXPECTEDLY NEGATIVE ANTIBODY SCREENS WHEN TESTED ON A GALILEO INSTRUMENT, WHEN TESTED BETWEEN (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7025327 ↗MalfunctionNov 13, 2017False Negative Result
ON 17OCT2017, A CUSTOMER SITE, REPORTED NINETEEN (19) HISTORICALLY UNEXPECTEDLY NEGATIVE ANTIBODY SCREENS WHEN TESTED ON A GALILEO INSTRUMENT, WHEN TESTED BETWEEN (B)(6) 2017. THE EARLIEST WAS ABOUT THREE (3) MONTHS PRIOR TO THEIR REPORTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7024991 ↗MalfunctionNov 2, 2017False Negative Result
ON 10OCT2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6996429 ↗MalfunctionNov 2, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6996414 ↗MalfunctionNov 2, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6996205 ↗MalfunctionAug 22, 2017False Negative Result
ON 06AUG2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6811439 ↗MalfunctionAug 22, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6810930 ↗MalfunctionAug 14, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A MANUAL CAPTURE WORKSTATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6793017 ↗MalfunctionJun 7, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE, REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6619772 ↗
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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