NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip — Class II medical device recall Z-1251-2022
Ongoing recall by NeuMoDx Molecular Inc, reported 2022-06-15, distributed in FL, MD, MI, NM, NY, PA, TN, VA. There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, a
| Recall number | Z-1251-2022 |
|---|---|
| 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 | 2022-05-13 |
| Classified | 2022-06-08 |
| Reported by FDA | 2022-06-15 |
| Distributed | FL, MD, MI, NM, NY, PA, TN, VA |
| UPC / GTIN / UDI-DI | 10814278020830 |
| Lot numbers | 111915, 117508 |
| Model numbers | 300900 |
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Reason for recall
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
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-1251-2022. 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.