VIDAS Varicella Zoster IgG — Class II medical device recall Z-1107-2020
Terminated recall by bioMerieux, Inc., reported 2020-02-19, distributed nationwide. Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the
| Recall number | Z-1107-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2019-12-10 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | 1007393380, 1007410330 |
| Model numbers | 30217-01 |
Product
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Reason for recall
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
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-1107-2020. 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.