BEUDAMED
    FDA Enforcement Class II Terminated

    Diamedix Is-CMV IgG Test Kit

    Recall: Z-1689-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1689-2016
    Event ID
    73194
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diamedix Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2016
    Initiation Date
    March 26, 2015
    Classification Date
    May 17, 2016
    Termination Date
    November 14, 2018
    Address
    14100 Nw 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    Description

    Diamedix Is-CMV IgG Test Kit

    Reason

    Product contained an incorrect substrate.

    Code Info

    Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016

    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