Device product
CMV IgM EIA, in vitro diagnostic.
Z-0342-2023
Product summary
- Event
- Event 91106
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180 kits
- Official record key
device-enforcement:Z-0342-2023
Official wording
Reason: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Code information: Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
Distribution pattern: U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
Derived failure modes
-
Unknown
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).