Capture-R Ready-Screen (I and II)Recalls & reported problems across all models
Immucor, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Capture-R Ready-Screen (I and II) by Immucor, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Apr 13, 2016 and Mar 12, 2025 — classified as 38 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Capture-R Ready-Screen (I and II) problems
Device problems
- False Negative Result37
- Incorrect Or Inadequate Test Results1
Patient problems
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient14
- Transfusion Reaction3
- No Clinical Signs, Symptoms or Conditions1
Capture-R Ready-Screen (I and II) models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 33 reports
- 3 reports
- 1 report
- 1 report
Recent Capture-R Ready-Screen (I and II) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025False Negative Result; False Negative Result
A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584487 ↗MalfunctionJul 18, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED THAT THEY HAD RECEIVED A NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THEIR NEO IRIS INSTRUMENT. THE PATIENT RECEIVED A TRANSFUSION, AND A DELAYED SEROLOGICAL REACTION WAS OBSERVED. SUBSEQUENTLY ANTI-C AND ANTI-JKB WERE IDENTIFIED.
Patient problems: Transfusion Reaction
MAUDE report 17347473 ↗MalfunctionMar 21, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY (MISSED ANTI-K) WITH CAPTURE-R READY-SCREEN 3 ON THEIR ECHO LUMENA INSTRUMENT.
Patient problems: Transfusion Reaction
MAUDE report 16587906 ↗MalfunctionMar 7, 2023False Negative Result; False Negative Result
ON (B)(6) 2023 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY (MISSED ANTI-S) WITH CAPTURE-R READY-SCREEN (I AND II) ON THEIR NEO IRIS INSTRUMENT.
Patient problems: Transfusion Reaction
MAUDE report 16496213 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN I & II 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 MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-C 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 10345949 ↗MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN I AND II I 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 MALFUNCTION DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E 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 9252130 ↗MalfunctionJul 12, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED A CORRELATION DISCREPANCY ON A NEO IRIS INSTRUMENT. ON (B)(6) 2019 ADDITIONAL INFORMATION WAS REPORTED THAT CHARACTERIZED THE EVENT AS UNEXPECTED NEGATIVE SCREENING RESULTS ON A NEO IRIS INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8786792 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 2 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471210 ↗MalfunctionApr 1, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN RESULTS USING CAPTURE-R READY-SCREEN 2 ON THE NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8471164 ↗MalfunctionDec 3, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT ON (B)(6) 2018 AND (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8126682 ↗MalfunctionJun 28, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7647118 ↗MalfunctionApr 20, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (I AND II) WITH A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7448368 ↗MalfunctionMar 22, 2018False Negative Result; False Negative Result
ON 27FEB2018, AN IMMUCOR EMPLOYEE VISITING A CUSTOMER SITE, REPORTED ON BEHALF OF THE CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7361649 ↗MalfunctionDec 11, 2017False Negative Result
ON 15NOV2017, 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 Consequences Or Impact To Patient
MAUDE report 7105444 ↗MalfunctionNov 27, 2017False Negative Result
ON (B)(6) 2017, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN TESTED ON A GALILEO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7061340 ↗
Other Immucor, Inc. products
All Immucor, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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