BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1153-2013 · Initiated February 25, 2013

    Recall

    Recall Number
    Z-1153-2013
    Event Number
    64638
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 25, 2013
    Posted
    April 19, 2013
    Terminated
    September 26, 2014
    Address
    200 Prospect St, Waltham, MA, 02453

    Description

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

    Reason

    Glucose test strips reports no result message when tested

    Action

    The firm, Nova Biomedical, sent an "Urgent Field Safety Notice 01-13SS" dated March 18, 2013 and US customers notification by phone contact and to the International customers including a Faxback Form to be communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). The customers were instructed to INVALIDATE the Nova StatStrip Glucose Test Strip lots indicated in the list on all StatStrip meters within your institute; REPLACE all Nova StatStrip Glucose Test Strips from the indicated lots with replacement test strips provided by Nova; REMOVE all unused boxes of the Nova StatStrip Glucose Test Strip lots indicated from all locations within your institute; RETURN all unused boxes of the Nova StatStrip Glucose Test Strips lots indicated to Nova Biomedical U.K. or your local Nova distributor following the country specific instructions provided by your authorized Nova representative, and complete and return the Fax-Back Form via email or FAX to your Regional Service Manager at 781-8914806. On April 08, 2013, the firm expanded the recall notification to include one additional test strip lot #0313021309 which was shipped under two catalog numbers(Catalog # 42214 and Catalog# 51493). US Notification by phone contact with key customer contact facilitated by Senior Manger of Technical Support Services. International - Field Safety Notice and Faxback Form is being communicated to and sent to Nova Biomedical Subsidiary by two methods of delivery (Email and Phone Call). Questions regarding this notice should be directed to the following Nova Biomedical EU Authorized Representative at: Nova Biomedical Innovation House, Aston Lane South Runcorn,WA7 3FY Telephone: + 44 1244 287087 Email: [email protected]. or US at (781) 894-0800.

    Distribution

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

    Quantity

    7433 cases