FDA Device recall Z-1050-2022
Diagnostic Kit SARS-cCo V Antigen Rapid Test
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Diagnostic Kit SARS-cCo V Antigen Rapid Test by Usa Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1050-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-04 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Usa Medical |
| Distribution | US |
Product
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Reason
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.
Identifiers
| code_info | Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1050-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.