Recall Z-2408-2021— Versea Diagnostics LLC
Class II · Terminated
Class II FDA medical device recall by Versea Diagnostics LLC, initiated 2021-07-27, terminated 2024-04-10. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Versea Diagnostics LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-27
- Terminated
- 2024-04-10
- Firm location
- Tampa, FL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.