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    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·September 30, 2021

    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·September 30, 2021

    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·October 4, 2021

    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·September 30, 2021

    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·October 4, 2021

    FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QMN·December 4, 2024

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·September 22, 2021

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·October 5, 2021

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·October 5, 2021

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·October 5, 2021

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·September 24, 2021

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QMN·February 5, 2025

    FLOWFLEX PLUS COVID-19 AND FLU A/B HOME TEST

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code QMN·February 10, 2025

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code QMN·January 3, 2024

    INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

    FDA Recall
    Open, Classified ·PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR·Product code QMN·October 25, 2023

    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 nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)

    FDA Recall
    Terminated ·Versea Diagnostics LLC·Product code QMN·July 27, 2021

    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code QMN·May 1, 2023

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020

    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021

    FDA Recall
    Terminated ·VEO DIAGNOSTICS, LLC·Product code QMN·November 5, 2020

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020