Events

Recall of Device Recall Nova Max Glucose Test Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nova Biomedical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65617
  • Event Risk Class
    Class 1
  • Event Number
    Z-1906-2013
  • Event Initiated Date
    2013-07-15
  • Event Date Posted
    2013-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120660
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, test, blood glucose, over the counter - Product Code NBW
  • 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. .

Device

Device Recall Nova Max Glucose Test Strips
  • Model / Serial
    1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
  • Product Description
    Nova Max Plus Monitor System (Kit w/10 Count Vials International) || Catalog Number: 45507 || 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
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Manufacturer Address
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • Manufacturer Parent Company (2017)
    Nova Biomedical Corporation
  • Source
    USFDA