Events

Rappel de Device Recall Nova Max Glucose Test Strips

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Nova Biomedical Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    65617
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1901-2013
  • Date de mise en oeuvre de l'événement
    2013-07-15
  • Date de publication de l'événement
    2013-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119722
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, test, blood glucose, over the counter - Product Code NBW
  • Cause
    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
  • Modèle / numéro de série
    Lot #/Exp.Date: 1020212032 02/28/2014 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 1020811350 12/31/2013 102121304 02/28/2015
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
  • Description du dispositif
    Nova Max Glucose Test Strips (10 Count Vials) || Catalog Number: 43604 || These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 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
  • Adresse du fabricant
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • Société-mère du fabricant (2017)
    Nova Biomedical Corporation
  • Source
    USFDA