BEUDAMED
    FDA Enforcement Class I Terminated

    Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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-1898-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1898-2013
    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 Glucose Test Strips (50 Count DME) Catalog Number: 43523 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

    Lot #/Exp.Date: 1010312046 10/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020712206 07/31/2014 1020811350 12/31/2013 1020912292 10/31/2014

    Distribution

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

    Quantity

    32,452,700 test strips