Capture-CMV 0066206Recalls & 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 one plate product. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888234001157), received between May 10, 2016 and Nov 9, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2018False Positive Result; False Positive Result
ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED (B)(6) RESULTS WITH (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8057064 ↗MalfunctionMay 10, 2016False Positive Result
ON (B)(6) 2016, A CUSTOMER SITE REPORTED AN UNEXPECTEDLY POSITIVE CMV TEST WHEN USING CAPTURE-CMV ON A MANUAL CAPTURE WORKSTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5643983 ↗
Other Antigen, Iha, Cytomegalovirus devices
- Capture-CMV Indicator Red Cells 0066238Immucor, Inc. · Antigen, Iha, Cytomegalovirus1 report
- Capture-CMV 0066216Immucor, 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.