Home / Brands / Versea Diagnostics
Versea Diagnostics Recalls
4 recalls on record · September 8, 2021 to September 8, 2021 · Medical Devices
September 8, 2021Medical DevicesFDA
Versea Diagnostics LLC recalls Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A,
Hazard: Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
September 8, 2021Medical DevicesFDA
Versea Diagnostics LLC recalls Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of Ig
Hazard: Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
September 8, 2021Medical DevicesFDA
Versea Diagnostics LLC recalls FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-C
Hazard: Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
September 8, 2021Medical DevicesFDA
Versea Diagnostics LLC recalls CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the n
Hazard: Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.