Capture-R Ready-Screen (I and II) 0006439Recalls & 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.
All models of Capture-R Ready-Screen (I and II) (4)
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 10888234000631), received between Jan 10, 2017 and May 4, 2017 — classified as 3 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
- Incorrect Or Inadequate Test Results1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2017Incorrect Or Inadequate Test Results
ON (B)(6) 2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (I AND II) ON A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6545655 ↗MalfunctionApr 21, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE, WHILE VISITING 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 Known Impact Or Consequence To Patient
MAUDE report 6512687 ↗MalfunctionJan 10, 2017False Negative Result
ON 20DEC2016, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (I AND II) ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6239250 ↗
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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