Capture-CMV Indicator Red Cells 0066238Recalls & reported problems
Immucor, Inc. · Capture-CMV Indicator Red Cells are part of the Capture-CMV test, and they are used to visualize the final reaction. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234001232), received between Jul 26, 2016 and Jul 26, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive Result” (1 report).
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 Positive Result1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2016False Positive Result
ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED POSITIVE RESULTS WHEN TESTING A DONOR SAMPLE ON THE CMV ASSAY ON THE GALILEO NEO INSTRUMENT USING CAPTURE-CMV INDICATOR RED CELLS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5823260 ↗
Other Antigen, Iha, Cytomegalovirus devices
- Capture-CMV 0066206Immucor, Inc. · Antigen, Iha, Cytomegalovirus2 reports
- Capture-CMV 0066216Immucor, Inc. · Antigen, Iha, Cytomegalovirus1 report
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.
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