BEUDAMED
    FDA Enforcement Class II Terminated

    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214

    Recall: Z-1153-2013 · Reported May 1, 2013

    Enforcement

    Recall Number
    Z-1153-2013
    Event ID
    64638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nova Biomedical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 1, 2013
    Initiation Date
    February 25, 2013
    Classification Date
    April 19, 2013
    Termination Date
    September 26, 2014
    Address
    200 Prospect St, Waltham, MA, 02453, United States

    Description

    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214

    Reason

    Glucose test strips reports no result message when tested

    Code Info

    Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.

    Quantity

    7433 cases