BEUDAMED
    FDA Recall Terminated

    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control

    Recall: Z-1904-2013 · Initiated July 15, 2013

    Recall

    Recall Number
    Z-1904-2013
    Event Number
    65617
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    July 15, 2013
    Posted
    August 9, 2013
    Terminated
    August 1, 2017
    Address
    200 Prospect St, Waltham, MA, 02453

    Description

    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control

    Reason

    Reports of false abnormally high glucose readings from test strips

    Action

    Nova Biomedical U.S.A issued an Urgent Medical Device Voluntary Recall Letter dated July 19, 2013 via registered/certified letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use of the affected product; contact Nova Diabetes Care Customer Service for replacement strips; do not stop testing blood glucose while waiting for replacement strips; if affected strips must be used follow precautions provided in notification letter. For questions call Nova Diabetes Care Customer Service at 1-800-681-7390. .

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

    Quantity

    9,200