BEUDAMED
    FDA Recall Terminated

    Chembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid 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: 70-1069-0

    Recall: Z-2808-2020 · Initiated June 18, 2020

    Recall

    Recall Number
    Z-2808-2020
    Event Number
    86098
    Firm
    Chembio Diagnostics, Inc
    FEI Number
    2431980
    Product Code
    QKO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 18, 2020
    Terminated
    August 11, 2021
    Address
    3661 Horseblock Rd, Medford, NY, 11763-2215

    Description

    Chembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid 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: 70-1069-0

    Reason

    FDA revocation of the Emergency Use Authorization due to performance issues

    Action

    Chembio Diagnostic Systems issued written notification letter to each affected customer and distributor via e-mail on June 18, 2020. Letter states reason for recall, health risk and action to take:Chembio requested that the customers cease use of the product and return unused product to Chembio for a credit to your account. All customers were instructed to complete a returned goods authorization form and return to Chembio indicating the customer has received the notification and complied with the instructions. Chembio then contacted the customer and issued a Returned Goods Authorization number (RGA #) and further instructions for returning any unused DPP COVID-19 IgM/IgG System test devices and the DPP Micro Reader and/or DPP Micro Reader II to Chembio. Distributors were instructed to notify all consignees of this notification advising them of the situation and to cease use of the product and instruct them to return unused product. Customers will be issued credit or replacement as soon as possible upon return of any remaining unused product

    Distribution

    Nationwide

    Quantity

    126 kits