Events

Rappel de Alere INRatio / INRatio 2 PT/INR Monitoring System. 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 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-2016-RN-00999-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-08-03
  • 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-2016-RN-00999-1
  • 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
    In december 2014 (tga ref: rc-2014-rn-01289-1), alere initiated a correction to inform users of the alere inratio system that patients with certain medical conditions should not be tested with the system due to the potential, in certain cases, of the alere inratio system to provide an inr result that was significantly lower than a result obtained using a laboratory inr system. alere has recently decided to remove the alere inratio system from the market and to discontinue manufacturing the product line. alere will continue manufacturing and distributing the alere inratio test strips for a period of time to allow patients to safely transition to another monitoring method.
  • Action
    Alere is advising customers to transition to an alternative method to perform PT/INR testing as soon as possible. Alternate methods may include a plasma-based laboratory INR method or monitoring with a point-of-care system from a different manufacturer. After transitioning onto another system, the Alere system and remaining test strips must be returned to Alere. Customers can continue to use the Alere INRatio System until users have transitioned, as long as patients adhere to the precautions and recommendations found in the 2014 Recall for Product Correction letter and the current product insert. For further information, please see https://www.tga.gov.au/alert/alere-inratio-ptinr-monitor-system .

Device

Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)INRatio Prothrombin Time PT Monitoring SystemProduct Code: HS0100267INRatio 2 Professional Testing KitProduct Code: HS0200431INRatio 2 Home Monitoring KitProduct Code: HS0200433, HS0200433SJM, HS200433SJMKINRatio PT/INR Test StripsProduct Codes: HS0100071, HS0100139INRatio 2 PT/INR Test Strips Heparin-InsensitiveProduct Codes: HS99007G1, HS99008G1ARTG Number: 214252
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

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