BEUDAMED
    FDA Recall Terminated

    Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.

    Recall: Z-2006-2009 · Initiated June 10, 2009

    Recall

    Recall Number
    Z-2006-2009
    Event Number
    52449
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 10, 2009
    Posted
    September 16, 2009
    Terminated
    October 29, 2010
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.

    Reason

    There may be a significant negative bias when testing neonate samples.

    Action

    Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry. For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative.

    Distribution

    International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.

    Quantity

    1,518 of total products