FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and… — Class II medical device recall Z-2408-2021
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-2408-2021 |
|---|---|
| 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
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (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-2408-2021. 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.