Capture-R Ready-Screen (3) 0066815Recalls & reported problems
Immucor, Inc. · Capture-R Ready-Screen (3) 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 three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. 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. 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 (3) (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888234001478), received between Jul 11, 2016 and Aug 7, 2018 — classified as 9 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (7 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 Result7
- Unexpected Therapeutic Results2
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- No Information2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH AN ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7759387 ↗MalfunctionJun 27, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN AND ANTIBODY PANEL, WHEN USING CAPTURE-R READY-SCREEN (3) AND CAPTURE-R READY-ID WITH A GALILEO ECHO 2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7642534 ↗MalfunctionNov 15, 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 (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6103455 ↗MalfunctionNov 7, 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 (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6083374 ↗MalfunctionSep 27, 2016False Negative Result
A COMPLAINT WAS OPENED ON 05SEP2016, WHICH INDICATED THAT ON (B)(6) 2016, A CUSTOMER SITE IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5980963 ↗MalfunctionSep 27, 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 (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5980595 ↗MalfunctionSep 16, 2016Unexpected Therapeutic Results
ON (B)(6) 2016, A CUSTOMER SITE IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Information
MAUDE report 5957038 ↗MalfunctionSep 16, 2016Unexpected Therapeutic Results
ON (B)(6) 2016, A CUSTOMER SITE IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Information
MAUDE report 5957037 ↗MalfunctionJul 11, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5783693 ↗
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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