NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip — Class II medical device recall Z-0738-2022
Ongoing recall by NeuMoDx Molecular Inc, reported 2022-03-16, distributed nationwide. A risk for product contamination was identified for the affected product lot. If used, there is an increased p
| Recall number | Z-0738-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuMoDx Molecular Inc, Ann Arbor, MI, United States |
| Recall initiated | 2022-01-21 |
| Classified | 2022-03-08 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 102 boxes |
| UPC / GTIN / UDI-DI | 10814278020830 |
| Lot numbers | 116305, S/L-02 |
| Model numbers | 300900 |
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Reason for recall
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when 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-0738-2022. 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.