Events

Rappel de FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abbott Australasia Pty Ltd T/A Abbott Diabetes Care.

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
    RC-2013-RN-01228-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01228-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The affected freestyle lite blood glucose test strips may produce erroneously low blood glucose results and out of range control solution results when used with the freestyle papillon mini blood glucose meters.Blood glucose results are not affected if using the freestyle lite blood glucose monitoring system, freestyle insulinx, blood glucose monitoring system or freestyle freedom lite blood glucose monitoring system.
  • Action
    Consumers are requested to contact Abbott Diabetes Care immediately to organise replacement of the affected test strips. If no alternative test method is available customers should continue to use the affected lots and contact their healthcare professionals in the event of a reading that appears lower than expected. For further information, please see http://www.tga.gov.au/safety/alerts-device-freestyle-lite-blood-glucose-test-strips-131122.htm

Device

FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters)...
  • Modèle / numéro de série
    FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD)Product Number: 70984.70Lot Numbers: 1366540, 1366621
  • Manufacturer
    Abbott Australasia Pty Ltd T/A Abbott Diabetes Care

Manufacturer

Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA