Drug recall
CMV IgM EIA, in vitro diagnostic.
FDA recall event 91106 · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Event ID | 91106 |
|---|---|
| Recall numbers | Z-0342-2023 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Product type | Devices |
| Products | CMV IgM EIA, in vitro diagnostic. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). |
| Initiation date | Oct 19, 2022 |
| Report date | Dec 7, 2022 |
| City | Redmond |
| State | WA |
| Country | United States |
| FEI number | 3022521 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: