Capture-CMV 0066216Recalls & reported problems
Immucor, Inc. · Capture-CMV is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of donors or patients for serological evidence of previous infection by CMV. This is the five plate product. · Class 2
- 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 10888234002154), received between Oct 31, 2025 and Oct 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025False Negative Result; False Negative Result
A REVIEW OF QUARTERLY EVENTS INDICATED THAT FOR ONE TEST EVENTS USING THE CAPTURE-CMV, A MALFUNCTION OCCURRED RESULTING IN THE INSTRUMENT PRODUCING INCORRECT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442464 ↗
Other Antigen, Iha, Cytomegalovirus devices
- Capture-CMV 0066206Immucor, Inc. · Antigen, Iha, Cytomegalovirus2 reports
- Capture-CMV Indicator Red Cells 0066238Immucor, Inc. · Antigen, Iha, Cytomegalovirus1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.