FDA Device recall Z-0342-2023
CMV IgM EIA, in vitro diagnostic
- FDA Device
- Class II
- ongoing
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of CMV IgM EIA, in vitro diagnostic by Bio Rad Laboratories, citing due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0342-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-19 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, TX |
Product
CMV IgM EIA, in vitro diagnostic.
Reason
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Identifiers
| code_info | Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0342-2023%22
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