FDA Device recall Z-0742-2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx
- FDA Device
- Class II
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx by Biomerieux, citing invalid calibrations (out of range high) while using the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0742-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-09 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, WV |
Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Reason
Invalid calibrations (out of range high) while using the product.
Identifiers
| code_info | Lot numbers 1008873260, exp. 01JUN2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0742-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.