Capture-R Ready-Screen (3) 0066814Recalls & 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
Quick summary
This Immucor Capture-R Ready-Screen blood antibody test has 86 malfunction reports, with no deaths or injuries. The reports mostly describe unexpected negative results, where antibodies that were present were not detected, and a few mention transfusion reactions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10888234001461), received between May 3, 2016 and Aug 5, 2025 — classified as 86 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (85 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result85
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient60
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions2
- Transfusion Reaction2
- Patient Problem/Medical Problem1
- Reaction1
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT. CUSTOMER REPORTED A HEMOLYTIC TRANSFUSION REACTION WAS OBSERVED.
Patient problems: Transfusion Reaction
MAUDE report 22719142 ↗MalfunctionJun 9, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT. CUSTOMER REPORTED A DELAYED TRANSFUSION REACTION.
Patient problems: Transfusion Reaction
MAUDE report 22171789 ↗MalfunctionDec 23, 2022False Negative Result; False Negative Result
ON (B)(6) 2022 A CUSTOMER SITE IN THE UK REPORTED THAT THEY HAD RECEIVED UNEXPECTED NEGATIVE RESULTS FOR AN ANTIBODY SCREEN USING CAPTURE-R READY-SCREEN 3 ON THE EUROPEAN VERSION OF THE NEO IRIS INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16041119 ↗MalfunctionFeb 5, 2021False Negative Result; False Negative Result
ON JANUARY 8, 2021 A CUSTOMER IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THE NEO IRIS INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11290041 ↗MalfunctionMay 24, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER IN (B)(6) REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULTS WITH CAPTURE-R READY-SCREEN 3.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8640102 ↗MalfunctionMay 21, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8629457 ↗MalfunctionMay 8, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN ON THE NEO IRIS INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8592896 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6)2019, A EUROPEAN (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3), WHICH LED TO A TRANSFUSION REACTION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8471060 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471040 ↗MalfunctionDec 6, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3), WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8138113 ↗MalfunctionDec 4, 2018False Negative Result; False Negative Result
ON 15NOV2017, AN (B)(6) IMMUCOR DISTRIBUTOR REPORTED SOME UNEXPECTEDLY NEGATIVE ANTIBODY SCREENS WITH CAPTURE-R READY-SCREEN (3), WHEN TESTED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8130708 ↗MalfunctionNov 12, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, A (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3), WHEN TESTED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8062068 ↗MalfunctionOct 4, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, A EUROPEAN FRENCH CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3), WHEN TESTED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7933905 ↗MalfunctionOct 2, 2018False Negative Result; False Negative Result
ON (B)(6) 2017, A EUROPEAN (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN (3), WHEN TESTED ON A EUROPEAN NEO IRIS INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7927411 ↗MalfunctionJun 22, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7631403 ↗MalfunctionMay 11, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7507414 ↗MalfunctionApr 5, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED 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 7399192 ↗MalfunctionMar 19, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7350861 ↗MalfunctionFeb 28, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7302940 ↗MalfunctionFeb 9, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7260835 ↗MalfunctionNov 20, 2017False Negative Result
ON (B)(6) 2017, IT WAS DETERMINED THAT A (B)(6) EVENT WAS REPORTABLE AS AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7046022 ↗MalfunctionNov 20, 2017False Negative Result
ON (B)(6) 2017, IT WAS DETERMINED THAT A EUROPEAN (B)(6) EVENT WAS REPORTABLE AS AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7046011 ↗MalfunctionNov 20, 2017Mechanical Problem
ON (B)(6) 2017, IT WAS DETERMINED THAT A EUROPEAN GERMAN CUSTOMER SITE EVENT WAS REPORTABLE, WHEN TESTED ON A GALILEO NEO INSTRUMENT ON (B)(6) 2017 AND (B)(6) 2017 FOR A SINGLE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7045107 ↗MalfunctionNov 6, 2017False Negative Result
ON (B)(6) 2017 A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7004524 ↗MalfunctionNov 6, 2017False Negative Result
ON (B)(6) 2017, A EUROPEAN (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7004287 ↗
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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