BEUDAMED
    FDA Recall Terminated

    Diamedix Is-CMV IgG Test Kit

    Recall: Z-1689-2016 · Initiated March 26, 2015

    Recall

    Recall Number
    Z-1689-2016
    Event Number
    73194
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    LFZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2015
    Terminated
    November 14, 2018
    Address
    14100 Nw 57th Ct, Miami Lakes, FL, 33014-3107

    Description

    Diamedix Is-CMV IgG Test Kit

    Reason

    Product contained an incorrect substrate.

    Action

    On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.

    Distribution

    AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.

    Quantity

    150 kits