Capture-R Ready-Screen (Pooled Cells) 0066254Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234001317), received between Nov 12, 2018 and Aug 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 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 Result2
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER IN REPORTED AN UNEXPECTED NEGATIVE RESULT WITH CAPTURE-R READY-SCREEN (POOLED CELLS) ON A GALILEO NEO INSTRUMENT.
Patient problems: No Patient Involvement
MAUDE report 8903339 ↗MalfunctionNov 12, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A BRAZILIAN PRODUCT DISTRIBUTOR CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY 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 8061396 ↗
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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