VIDAS CMV IgM — Class II medical device recall Z-0742-2022
Terminated recall by bioMerieux, Inc., reported 2022-10-05, distributed in CA, FL, GA, IL, IN, LA, MA, MD…. Invalid calibrations (out of range high) while using the product.
| Recall number | Z-0742-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2022-02-09 |
| Classified | 2022-03-14 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2026-04-01 |
| Distributed | CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, WV |
| Quantity | 480 kits |
| Lot numbers | 1008873260 |
| Model numbers | 30205-01 |
| Expiration dates | 2022-06-01 |
Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Reason for recall
Invalid calibrations (out of range high) while using the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0742-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.