BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0827-2015 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-0827-2015
    Event Number
    69622
    Firm
    JAS Diagnostics Inc.
    FEI Number
    3003071743
    Product Code
    CFR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2014
    Posted
    December 18, 2014
    Terminated
    February 26, 2015
    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

    Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

    Action

    On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.

    Distribution

    Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.

    Quantity

    390