FDA Device recall Z-2408-2021
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous…
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous… by Versea Diagnostics, citing products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authoriza….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2408-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-27 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Versea Diagnostics |
| Distribution | US |
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
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Identifiers
| code_info | all lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2408-2021%22
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