Diagnostic Kit SARS-cCo V Antigen Rapid Test — Class II medical device recall Z-1050-2022
Ongoing recall by USA Medical, LLC, reported 2022-05-18, distributed nationwide. COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared
| Recall number | Z-1050-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | USA Medical, LLC, Grapevine, TX, United States |
| Recall initiated | 2022-04-04 |
| Classified | 2022-05-06 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,055 kits |
Product
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Reason for recall
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
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-1050-2022. 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.