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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2407-2021 - 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 ... 2 09/03/2021 Versea Diagnostics LLC
Z-2410-2021 - Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of ... 2 09/03/2021 Versea Diagnostics LLC
Z-2409-2021 - Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+... 2 09/03/2021 Versea Diagnostics LLC
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 whole blood (sodium EDTA), serum, plasma (sodium EDTA) and ... 2 09/03/2021 Versea Diagnostics LLC
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