Drug recall
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
FDA recall event 89568 · Class II · bioMerieux, Inc.
Key facts
| Event ID | 89568 |
|---|---|
| Recall numbers | Z-0742-2022 |
| Recalling firm | bioMerieux, Inc. |
| Product type | Devices |
| Products | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Invalid calibrations (out of range high) while using the product. |
| Initiation date | Feb 9, 2022 |
| Report date | Oct 5, 2022 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3002769706 |
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: