Status COVID-19/Flu Rapid Immunoassay for Direct Detection and… — Class II medical device recall Z-2410-2021
Terminated recall by Versea Diagnostics LLC, reported 2021-09-08, distributed nationwide. Products may have been distributed to customers other than laboratories certified under the Clinical Laborator
| Recall number | Z-2410-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Versea Diagnostics LLC, Tampa, FL, United States |
| Recall initiated | 2021-07-27 |
| Classified | 2021-09-02 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 563,290 in |
Product
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)
Reason for recall
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
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-2410-2021. 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.