Capture-R Ready-IDRecalls & 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Capture-R Ready-ID by Immucor, Inc. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2016 and Sep 5, 2025 — classified as 62 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (59 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-ID problems
Device problems
- False Negative Result59
- Device Operates Differently Than Expected1
- False Positive Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient38
- No Consequences Or Impact To Patient20
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- Test Result1
Capture-R Ready-ID models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 38 reports
- 24 reports
Recent Capture-R Ready-ID adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY ID RESULT FOR CAPTURE-R READY-ID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986519 ↗MalfunctionSep 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY ID RESULT FOR CAPTURE-R READY-ID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986518 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT SIX (6) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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 TWO (2) OCCASIONS; THE ANTI-K ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-D ON ONE (1) OCCASION AND THE ANTI-KPA 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 10346450 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT EIGHT (8) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED NINE (9) 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 ONE (1) OCCASION; THE ANTI-E ANTIBODY ON THREE (3) OCCASIONS; THE ANTI-K ANTIBODY ON ONE (1) OCCASION; THE ANTI-M ANTIBODY ON ONE (1) OCCASION; THE ANTI-FYA ON TWO (2) OCCASIONS AND 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 10016366 ↗MalfunctionJan 29, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FIFTEEN (15) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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 ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON NINE (9) OCCASIONS; THE ANTI-K ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-CW ANTIBODY ON ONE (1) OCCASION AND THE ANTI-LUB 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 9644667 ↗MalfunctionOct 29, 2019False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT SEVEN (7) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY ID 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 ONE (1) OCCASION; THE ANTI-C ANTIBODY ON ONE (1) OCCASION; THE ANTI-D ANTIBODY ON ONE (1) OCCASION AND THE ANTI-E ANTIBODY ON FOUR (4) 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 9252080 ↗MalfunctionMay 21, 2019False Positive Result; False Positive Result
ON (B)(6) 2019 A CUSTOMER IN (B)(6) REPORTED UNEXPECTED NEGATIVE RESULTS WITH CAPTURE-R READY-ID ON THE EU VERSION OF GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8628897 ↗MalfunctionFeb 19, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A (B)(6) CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8350059 ↗MalfunctionFeb 11, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8327035 ↗MalfunctionJan 22, 2019False Negative Result; False Negative Result
ON (B)(6) 2019 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID ON AN ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8268760 ↗MalfunctionJan 22, 2019False Negative Result; False Negative Result
ON (B)(6) 2019, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8267993 ↗MalfunctionJan 21, 2019False Negative Result; False Negative Result
ON (B)(4) 2019, A (B)(6) CUSTOMER REPORTED, VIA EMAIL, AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8264389 ↗MalfunctionJan 21, 2019False Negative Result; False Negative Result
ON (B)(4) 2019, A (B)(6) CUSTOMER REPORTED, VIA EMAIL, AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON A GALILEO NEO INSTRUMENT, WHEN TESTED ON (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8264381 ↗MalfunctionJan 17, 2019False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID ON AN ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8257234 ↗MalfunctionJan 16, 2019False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY-ID ON AN ECHO V2.0 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8253557 ↗
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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