BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0827-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0827-2015
    Event ID
    69622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    JAS Diagnostics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    October 23, 2014
    Classification Date
    December 17, 2014
    Termination Date
    February 26, 2015
    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

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

    Code Info

    Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.

    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