BEUDAMED
    FDA Recall Terminated

    Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.

    Recall: Z-1590-2009 · Initiated May 13, 2009

    Recall

    Recall Number
    Z-1590-2009
    Event Number
    51963
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    FMK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2009
    Posted
    August 11, 2009
    Terminated
    January 5, 2011
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.

    Reason

    The lancet cap may be missing, which could result in an unintended lancet stick to the user.

    Action

    An "Urgent Medical Device Correction" letter dated May 13, 2009 was sent to all affected customers, distributors and consumer consignees who have either registered their blood glucose meter, contacted the firm about the lancets since 10/1/08, or have been shipped lancets by Roche since 10/1/08 were notified of the problem. Distributors were requested to notify each patient self-tester to whom a meter kit was distributed since October 1, 2008. The firm issued a press release on May 18, 2009. Diabetes Care customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7057. CoaguChek meter customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7505.

    Distribution

    Nationwide.

    Quantity

    449,533 packages of lancets