BEUDAMED
    FDA Enforcement Class II Terminated

    Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0

    Recall: Z-2807-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2807-2020
    Event ID
    86098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Chembio Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2020
    Initiation Date
    June 18, 2020
    Classification Date
    August 14, 2020
    Termination Date
    August 11, 2021
    Address
    3661 Horseblock Rd, N/A, Medford, NY, 11763-2215, United States

    Description

    Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0

    Reason

    FDA revocation of the Emergency Use Authorization due to performance issues

    Code Info

    Lot Numbers: CV041020/A CV041520 CV040220/A1 CV042420 CV042920 CV040320/A2 CV050120

    Distribution

    Nationwide

    Quantity

    7,674 kits (153,480 devices)