Capture-R Ready-Screen (3) 0066803Recalls & 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.
All models of Capture-R Ready-Screen (3) (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888234001416), received between Jul 26, 2016 and Mar 11, 2019 — classified as 16 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (16 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 Result16
Patient problems
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2019False Negative Result; False Negative Result
ON FEBRUARY 15, 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 3 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8410165 ↗MalfunctionMar 11, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 3 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8410010 ↗MalfunctionNov 9, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-SCREEN 3 ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8054914 ↗MalfunctionJan 3, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, AN IMMUCOR EMPLOYEE AT A (B)(4) CUSTOMER SITE REPORTED ON BEHALF OF THE CUSTOMER SITE AN UNEXPECTED NEGATIVE ANTIBODY VALIDATION OUTCOMES WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2017.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7160559 ↗MalfunctionAug 15, 2017False Negative Result
ON 26JUL2017, IT WAS DETERMINED THAT INFORMATION FROM (B)(6)2017, FROM A (B)(6) CUSTOMER SITE WHICH REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN TO AN IMMUCOR EMPLOYEE WHEN THAT EMPLOYEE HAPPENED TO BE VISITING THE CUSTOMER SITE, WAS REPORTABLE, WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT. TESTING HAPPENED ON (B)(6)2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6795165 ↗MalfunctionAug 15, 2017False Negative Result
ON (B)(6)2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6794582 ↗MalfunctionAug 15, 2017False Negative Result
ON (B)(6)2017, A CANADIAN CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6794581 ↗MalfunctionAug 15, 2017False Negative Result
ON 26JUL2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT. TESTING HAPPENED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6794113 ↗MalfunctionAug 15, 2017False Negative Result
ON (B)(6) 2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6794112 ↗MalfunctionAug 3, 2017False Negative Result
ON (B)(6)2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN TO AN IMMUCOR EMPLOYEE WHEN THAT EMPLOYEE HAPPENED TO BE VISITING THE CUSTOMER SITE, WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6763645 ↗MalfunctionAug 3, 2017False Negative Result
ON (B)(6)2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN TO AN IMMUCOR EMPLOYEE WHEN THAT EMPLOYEE HAPPENED TO BE VISITING THE CUSTOMER SITE, WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT. TESTING HAPPENED ON (B)(6)2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6763237 ↗MalfunctionJul 17, 2017False Negative Result
ON (B)(6) 2017, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6718614 ↗MalfunctionOct 10, 2016False Negative Result
ON (B)(6) 2016 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A PATIENT SAMPLE USING CAPTURE-R READY-SCREEN 3 (CRRS 3) ON THE GALILEO ECHO INSTRUMENT SERIAL NUMBER (B)(4). THE SAMPLE WAS FROM A PATIENT WITH A HISTORY OF ANTI-KELL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6015210 ↗MalfunctionAug 2, 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 5839870 ↗MalfunctionAug 2, 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 Consequences Or Impact To Patient
MAUDE report 5839751 ↗MalfunctionJul 26, 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, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5822127 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page