Capture-R Ready Indicator Red CellsRecalls & reported problems across all models
Immucor, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Capture-R Ready Indicator Red Cells by Immucor, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2016 and Mar 2, 2022 — classified as 59 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (56 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
Most reported Capture-R Ready Indicator Red Cells problems
Device problems
- False Negative Result56
- Incorrect, Inadequate or Imprecise Result or Readings2
- Incorrect Or Inadequate Test Results1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient30
- No Consequences Or Impact To Patient23
- No Code Available2
- Fever1
- No Information1
- Patient Problem/Medical Problem1
- Test Result1
Capture-R Ready Indicator Red Cells models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Capture-R Ready Indicator Red Cells 0006428Kit, Quality Control For Blood Banking Reagents52 reports
- Capture-R Ready Indicator Red Cells 0006427Kit, Quality Control For Blood Banking Reagents7 reports
Recent Capture-R Ready Indicator Red Cells adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2022False Negative Result; False Negative Result
ON (B)(6) 2022, A CUSTOMER REPORTED A SUSPECTED DELAYED TRANSFUSION REACTION WITH A PATIENT WHOSE SAMPLES WERE INITIALLY NEGATIVE BY SCREEN AND ID, BUT ANTI-S WAS IDENTIFIED WITH LATER SAMPLE.
Patient problems: Fever
MAUDE report 13657144 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOUR (4) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY INDICATOR CELLS 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 RESULTS PRODUCED FALSE NEGATIVES BASED ON EXPECTATIONS FOR THE ANTI-E ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-E ANTIBODY ON ONE (1) OCCASION 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. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: Test Result
MAUDE report 10346483 ↗MalfunctionJan 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING CAPTURE-R READY INDICATOR CELLS REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED NEGATIVE RESULT FOR A SPECIFIC ANTIBODY. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. THE MALFUNCTION DID NOT SHOW A POSITIVE RESULT AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9650016 ↗MalfunctionJan 3, 2020False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9548822 ↗MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT THREE (3) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY INDICATOR CELLS 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 ON ONE (1) OCCASION; THE ANTI-CW ANTIBODY ON ONE (1) OCCASION AND THE ANTI-D 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 9252073 ↗MalfunctionJul 19, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE SCREEN AND ID RESULTS ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8808940 ↗MalfunctionMay 20, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT ON A GALLIEO ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8624725 ↗MalfunctionApr 26, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT FOR A SCREEN ASSAY ON A GALILEO ECHO V2 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8558105 ↗MalfunctionApr 23, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS FOR A CROSSMATCH ON THE ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8540049 ↗MalfunctionApr 19, 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 GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533251 ↗MalfunctionJan 18, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON AN ECHO LUMENA INSTRUMENT, WHEN TESTED ON (B)(6) 2018, WHICH LED TO AN EVENT BEING CATEGORIZED AS A DELAYED HEMOLYTIC TRANSFUSION REACTION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8261112 ↗MalfunctionDec 5, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8135344 ↗MalfunctionDec 3, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8126233 ↗MalfunctionNov 1, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED TO IMMUCOR TECHNICAL SUPPORT, ON BEHALF OF A CUSTOMER SITE, AN UNEXPECTEDLY NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8029563 ↗MalfunctionSep 13, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY INDICATOR RED CELLS ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7874323 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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