Capture-R Ready-Screen (3) 0066813Recalls & 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 test has 200 adverse event reports, with no deaths and no injuries. Most reports describe false negative results, where the test missed antibodies that were present, and some describe transfusion reactions. There are no recalls that 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
- 200
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 200 adverse event reports that list this exact device (DI 10888234001454), received between Apr 20, 2016 and Apr 4, 2023 — classified as 200 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (187 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 Result187
- Device Operates Differently Than Expected5
- Incorrect, Inadequate or Imprecise Result or Readings5
- Adverse Event Without Identified Device or Use Problem1
- False Reading From Device Non-Compliance1
- Improper Device Output1
- Incorrect Or Inadequate Test Results1
Patient problems
- No Known Impact Or Consequence To Patient104
- No Consequences Or Impact To Patient79
- Patient Problem/Medical Problem5
- Chills3
- No Clinical Signs, Symptoms or Conditions3
- Fever2
- No Code Available2
- No Information2
Recent adverse event reports
The 25 most recent of 200 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2023False Negative Result; False Negative Result
ON (B)(6) 2023, A CUSTOMER STATED THAT A PATIENT HAD A TRANSFUSION REACTION FOLLOWING RECEIPT OF ONE UNIT OF K+ BLOOD.
Patient problems: Transfusion Reaction
MAUDE report 16679202 ↗MalfunctionDec 30, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN WITH CAPTURE-R READY-SCREEN 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122321 ↗MalfunctionNov 27, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT FOR PRE-TRANSFUSION SAMPLE WITH USING CAPTURE-R READY-SCREEN 3 ON AN ECHO V2.0 INSTRUMENT AND A DELAYED TRANSFUSION REACTION WITH ONE PATIENT.
Patient problems: Jaundice
MAUDE report 12879735 ↗MalfunctionOct 2, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT FOR PRE-TRANSFUSION SAMPLE WITH USING CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT AND A HEMOLYTIC TRANSFUSION REACTION WITH ONE PATIENT. CUSTOMER STATED THAT THIS IS A SAMPLE RELATED ISSUE.
Patient problems: Chest Pain; Chills
MAUDE report 12566238 ↗MalfunctionJun 8, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED THAT A PATIENT HAD A SUSPECTED FEBRILE HEMOLYTIC REACTION WHEN RECEIVING PART OF ONE BLOOD UNIT THAT WAS ELECTRONICALLY CROSS MATCHED BASED ON NEGATIVE ECHO LUMENA SCREEN RESULT.
Patient problems: Chills
MAUDE report 11953906 ↗MalfunctionApr 13, 2021False Negative Result; False Negative Result
ON MARCH 15, 2021 A CUSTOMER REPORTED THAT A PATIENT HAD A TRANSFUSION REACTION CONSISTING OF CHILLS, RIGORS, AND ELEVATED BLOOD PRESSURE FOLLOWING TRANSFUSION OF A HALF UNIT OF K+ PRBC. PATIENT PRESENTED (B)(6) 2021 AS ANTIBODY SCREEN NEGATIVE. PATIENT RECEIVED MULTIPLE TRANSFUSIONS; ON FINAL UNIT (WHICH WAS (B)(6) 2021) A TRANSFUSION REACTION OCCURRED.
Patient problems: Chills
MAUDE report 11657055 ↗MalfunctionApr 7, 2021False Negative Result; False Negative Result
ON MARCH 12, 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 LOT NUMBER R205 ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11632189 ↗MalfunctionDec 18, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11039727 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 14 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOURTEEN (14) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-FYA ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-K ANTIBODY ON FOUR (4) OCCASIONS; THE ANTI-JKB ANTIBODY ON ONE (1) OCCASION; THE ANTI-S ANTIBODY ON ONE (1) OCCASION AND THE ANTI-CW ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10345919 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TEN (10) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ANTIBODY ON SIX (6) OCCASIONS; THE ANTI-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-K ANTIBODY ON ONE (1) OCCASION AND THE ANTI-JKA ANTIBODY ON TWO (2) OCCASIONS. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10016302 ↗MalfunctionApr 13, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9955535 ↗MalfunctionMar 30, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9901924 ↗MalfunctionMar 10, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED (B)(6) ANTIBODY SCREEN RESULT ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9813230 ↗MalfunctionMar 10, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT ON THE GALILEO ECHO V2.0 INSTRUMENT. FOLLOWING THE NEGATIVE SCREEN THE PATIENT RECEIVED TWO UNITS OF RBCS AND A DELAYED SEROLOGICAL REACTION WAS NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9812832 ↗MalfunctionJan 29, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT NINETEEN (35) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON FIVE (5) OCCASIONS; THE ANTI-FYA ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-D ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-E ANTIBODY ON FIVE (5) OCCASIONS; THE ANTI-K ANTIBODY ON SEVEN (7) OCCASIONS; THE ANTI-FYB ANTIBODY ON FOUR (4) OCCASIONS; THE ANTI-JKB ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-S ANTIBODY ON TWO (2) OCCASIONS AND THE ANTI-CW ANTIBODY ON TWO (2) OCCASIONS. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVES
Patient problems: Test Result
MAUDE report 9644460 ↗MalfunctionDec 18, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS WITH CAPTURE-R READY SCREEN 3 ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9491774 ↗MalfunctionDec 18, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS WITH CAPTURE-R READY SCREEN 3 ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9491728 ↗MalfunctionNov 19, 2019False Negative Result; False Negative Result
ON (B)(6), 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR AN ANTIBODY SCREEN ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9343650 ↗MalfunctionOct 28, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 19 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT NINETEEN (19) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-FYA ANTIBODY ON FOUR (4) OCCASIONS; THE ANTI-C ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-C ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-D ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-E ANTIBODY ON FIVE (5) OCCASIONS; THE ANTI-K ANTIBODY ON FOUR (4) OCCASIONS AND THE ANTI-K ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. ONE (1) NEGATIVE ANTIBODY RESULT FROM A MALFUNCTION EVENT FOUND AFTER A FIELD INVESTIGATION THAT USER ERRORS OCCURRED DURING PATIENT SAMPLE TESTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9246255 ↗MalfunctionOct 8, 2019False Negative Result; False Negative Result
ON AUGUST 24, 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULTS ON THE GALILEO NEO AND GALILEO ECHO INSTRUMENTS, RESULTING IN A PATIENT HAVING A DELAYED TRANSFUSION REACTION AFTER RECEIVING ANTIGEN-POSITIVE UNITS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9167725 ↗MalfunctionAug 20, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULTS WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8912027 ↗MalfunctionJul 31, 2019False Negative Result; False Negative Result
ON JULY 22, 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT USING CAPTURE-R READY-SCREEN 3 ON THE GALILEO ECHO V2.0 INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8847366 ↗MalfunctionJul 16, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS FOR AN ANTIBODY SCREEN ON THE GALILEO ECHO V2.0 INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8796090 ↗MalfunctionJun 27, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, AN IMMUCOR EMPLOYEE REPORTED, ON BEHALF OF A CUSTOMER SITE AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8739517 ↗MalfunctionJun 24, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8728520 ↗
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