CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of… — Class II medical device recall Z-2407-2021
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-2407-2021 |
|---|---|
| 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
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (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-2407-2021. 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.