BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1873-2014 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-1873-2014
    Event Number
    68343
    Firm
    JAS Diagnostics Inc.
    FEI Number
    3003071743
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 7, 2014
    Posted
    June 25, 2014
    Terminated
    August 21, 2014
    Address
    14100 Nw 57th Ct, Miami Lakes, FL, 33014-3107

    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.

    Action

    JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.

    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