Capture-R Ready-Screen (Pooled Cells) 0006436Recalls & reported problems
Immucor, Inc. · Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into 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.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888234001959), received between Jun 3, 2016 and Jul 30, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (4 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 Result4
- Incorrect Or Inadequate Test Results1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 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 TWO (2) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN POOLED 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-M ANTIBODY ON ONE (1) OCCASION AND 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 10347320 ↗MalfunctionApr 30, 2020False 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 SCREEN POOLED 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-M ANTIBODY ON ONE (1) OCCASION; THE ANTI-D ANTIBODY ON ONE (1) OCCASION AND THE ANTI-JKA 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 10016378 ↗MalfunctionMay 9, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED (B)(6) SCREEN WHEN USING CAPTURE-R READY-SCREEN (POOLED CELLS) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7498770 ↗MalfunctionFeb 17, 2017Incorrect Or Inadequate Test Results
ON 26JAN2017, A CUSTOMER SITE REPORTED VIA FAX AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (POOLED CELLS) ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6339253 ↗MalfunctionJun 3, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE AND WEAK REACTIVITY RESULTS WITH CAPTURE-R READY SCREEN (POOLED) PLATES DURING VALIDATION ON GALILEO NEO (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5698827 ↗
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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