BEUDAMED
    FDA Enforcement Class III Terminated

    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

    Recall: Z-2574-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2574-2018
    Event ID
    80441
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diamedix Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    January 5, 2018
    Classification Date
    July 28, 2018
    Termination Date
    November 5, 2019
    Address
    14100 Nw 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    Description

    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640

    Reason

    Contains a gel-like contaminant that may affect product performance.

    Code Info

    Lot T0006 Exp. 05/31/2018

    Distribution

    AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI

    Quantity

    147