BEUDAMED
    FDA Enforcement Class I Terminated

    Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: 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-1905-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1905-2013
    Event ID
    65617
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nova Biomedical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    July 15, 2013
    Classification Date
    August 9, 2013
    Termination Date
    August 1, 2017
    Address
    200 Prospect St, Waltham, MA, 02453, United States

    Description

    Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: 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

    Code Info

    1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013

    Distribution

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

    Quantity

    28,240 kits