Z-0342-2023 Class II Ongoing
FDA device recall Z-0342-2023 was initiated by Bio-Rad Laboratories, Inc. on October 19, 2022 and is designated Class II. Reason for recall: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). The recall status is ongoing. Affected quantity: 180 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 kits
Product Description
CMV IgM EIA, in vitro diagnostic.
Reason for Recall
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Distribution Pattern
U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
Code Information
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022