BEUDAMED
    FDA Recall Terminated

    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

    Recall: Z-1687-2016 · Initiated October 20, 2014

    Recall

    Recall Number
    Z-1687-2016
    Event Number
    73694
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    GNP
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 20, 2014
    Terminated
    December 14, 2016
    Address
    14100 Nw 57th Ct, Miami Lakes, FL, 33014-3107

    Description

    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

    Reason

    A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

    Action

    The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.

    Distribution

    Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.

    Quantity

    94 kits