BEUDAMED
    FDA Enforcement Class II Terminated

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    Recall: Z-1873-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1873-2014
    Event ID
    68343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    JAS Diagnostics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    April 7, 2014
    Classification Date
    June 25, 2014
    Termination Date
    August 21, 2014
    Address
    14100 Nw 57th Ct, N/A, Miami Lakes, FL, 33014-3107, United States

    Description

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    Reason

    JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

    Code Info

    LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.

    Distribution

    Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.

    Quantity

    407