Capture-R Ready-Screen (4) 0066802Recalls & reported problems
Immucor, Inc. · Capture-R Ready-Screen (4) is used 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 four (4) test wells coated with red blood cell membranes. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch.
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234001409), received between May 5, 2016 and Jul 10, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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 Result3
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 4 RUN ON THE EUROPEAN MODEL OF THE NEO IRIS INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8776421 ↗MalfunctionAug 9, 2016False Negative Result
ON (B)(6) 2016, AN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (4) ON A GALILEO NEO INSTRUMENT.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 5857667 ↗MalfunctionMay 5, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER SITE IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (4) ON BOTH A GALILEO AND A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5634966 ↗
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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