Events

Rappel de Alere INRatio2 PT/INR Heparin Insensitive Test Strips

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Inverness Medical Innovations Australia Pty Ltd T/A Alere.

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-2014-RN-00471-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-05
  • 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-2014-RN-00471-1
  • 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
    This action is being initiated as a result of post-market surveillance information in the united states (usa), where it has been noted that in rare circumstances patients who return a therapeutic or near therapeutic inr result using the alere inratio2 pt/inr heparin insensitive test strips have had a significantly higher inr (outside of the therapeutic range) when performed within 1 hour to 1 day by a central laboratory.
  • Action
    Alere is notifying healthcare providers of an update to the limitations of use for the INRatio 2 PT/INR tests strips. Additionally, consumers are being provided with a Safety Alert notification advising of potential issues with the accuracy of the device and the correct clinical practice with regard to medication dosing. For more details, please see http://www.tga.gov.au/safety/alerts-device-alere-inratio2-140508.htm

Device

Alere INRatio2 PT/INR Heparin Insensitive Test Strips

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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