BEUDAMED
    FDA Enforcement Class II 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 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1687-2016
    Event ID
    73694
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diamedix Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 25, 2016
    Initiation Date
    October 20, 2014
    Classification Date
    May 16, 2016
    Termination Date
    December 14, 2016
    Address
    14100 Nw 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    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.

    Code Info

    Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015

    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