Covid-19 Multi-Analyte Antigen Device
FDA product code QMN · Not classified · Microbiology
A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.
0510(k) clearances
0PMA approvals
7recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1086-2024 Class II | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich…One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The… | Quidel Corporation | 01/03/2024Open, Classified |
| Z-0738-2024 Class II | INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when… | Phase Scientific International Limited | 10/25/2023Open, Classified |
| Z-1682-2023 Class II | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test…IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the… | Becton Dickinson & Co. | 05/01/2023Open, Classified |
| Z-2410-2021 Class II | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of…Products may have been distributed to customers other than laboratories certified under the Clinical… | Versea Diagnostics LLC | 07/27/2021Terminated |
| Z-0510-2021 Class II | ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U…Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests | Veo Diagnostics, LLC | 11/05/2020Terminated |
| Z-0451-2021 Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in…Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic… | Ortho Clinical Diagnostics Inc | 09/30/2020Terminated |
| Z-0450-2021 Class II | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro…Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic… | Ortho Clinical Diagnostics Inc | 09/30/2020Terminated |