VIDAS¿ CMV IgM 30 Tests — Class II medical device recall Z-1408-2021
Terminated recall by Biomerieux Inc, reported 2021-04-21, distributed nationwide. bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ;
| Recall number | Z-1408-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-04-10 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2024-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BG, BH, BO, BR, CH, CL, CO, CR, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, GT, HK, HR, HU, ID, IL, IN, IQ, IR, IT, JP, KE, KR, LB, LT, MA, MT, MX, NI, NL, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VN, ZA |
| Quantity | 18,705 kits |
| Lot numbers | 1008143230, 1008143260 |
| Model numbers | 30205, 30205-01 |
| Expiration dates | 2021-05-04, 2021-05-26, 2021-09-01, 2021-10-15 |
Product
VIDAS¿ CMV IgM 30 Tests
Reason for recall
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
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-1408-2021. 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.