Capture-R Ready-ID 0066204Recalls & reported problems
Immucor, Inc. · Capture-R Ready-ID is used in the detection and identification of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product is a double-strip configuration which carry the bound and dried membranes prepared from 14 group O donors. Each microplate contains six (6) double-strips, and the plate is sealed in a pouch.
All models of Capture-R Ready-ID (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Immucor Capture-R Ready-ID test is used to detect and identify antibodies against red blood cells. The 24 reports mostly describe unexpectedly negative antibody identification results on Galileo instruments, with no deaths and no injuries mentioned. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888234001140), received between Sep 1, 2016 and Feb 19, 2019 — classified as 24 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (22 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 Result22
- Device Operates Differently Than Expected1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient20
- No Consequences Or Impact To Patient3
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
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 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 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 ↗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 8253455 ↗MalfunctionJan 14, 2019False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(4) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON AN ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8246164 ↗MalfunctionJan 14, 2019False Negative Result; False Negative Result
ON (B)(6) 2018, A EUROPEAN (B)(6) CUSTOMER REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION OUTCOME WHEN USED ON AN ECHO LUMENA INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8246112 ↗MalfunctionNov 8, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-ID ON THE ECHO V2 INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8052501 ↗MalfunctionNov 7, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-ID ON THE ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8048214 ↗MalfunctionNov 7, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-ID ON THE ECHO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8048186 ↗MalfunctionOct 22, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SITE AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID, WHEN USED ON A GALILEO ECHO INSTRUMENT ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7992440 ↗MalfunctionAug 7, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7758503 ↗MalfunctionJul 30, 2018False Negative Result; False Negative Result
ON 16JUL2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7731527 ↗MalfunctionJul 30, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7731501 ↗MalfunctionJul 10, 2018False Negative Result; False Negative Result
ON (B)(6) 2018 A CUSTOMER REPORTED THAT THEY RECEIVED UNEXPECTED (B)(6) ON CAPTURE-R READY ID LOT ID360 (EXPIRY JULY 24, 2018) ON ECHO SERIAL NUMBER (B)(4), WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7674562 ↗MalfunctionApr 25, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, AN IMMUCOR EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER SITE AN UNEXPECTEDLY NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7462510 ↗MalfunctionApr 11, 2018False Negative Result; False Negative Result
ON (B)(6) 2018, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2018.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7422589 ↗MalfunctionAug 17, 2017False Negative Result
ON (B)(6)2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6800719 ↗MalfunctionMar 7, 2017False Negative Result
ON 17FEB 2017, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT, SERIAL NUMBER (B)(4), WHEN TESTED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6383859 ↗MalfunctionJan 18, 2017False Negative Result
ON (B)(6) 2017, AN IMMUCOR FIELD SERVICE ENGINEER (FSE) REPORTED FOR A (B)(6) CUSTOMER SITE AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO INSTRUMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6260310 ↗MalfunctionOct 26, 2016Device Operates Differently Than Expected
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE (B)(6) WITH CAPTURE-R READY-ID LOT ID298 ON THE GALILEO ECHO INSTRUMENT.
Patient problems: No Information
MAUDE report 6057848 ↗MalfunctionOct 26, 2016Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING PATIENT SAMPLE (B)(6) WITH CAPTURE-R READY-ID ON THE GALILEO ECHO INSTRUMENT. SAMPLE IS KNOWN TO CONTAIN AN ANTI-FYA. NO ADVERSE EVENT OCCURRED. TESTING WAS FOR VALIDATION PURPOSES ONLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6057846 ↗MalfunctionSep 1, 2016False Negative Result
ON 11AUG2016, A CUSTOMER SITE REPORTED AN UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION WHEN USING CAPTURE-R READY-ID WHEN USED ON A GALILEO ECHO, WHEN TESTED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5922717 ↗
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