Events

Rappel de Alere INRatio & INRatio2 PT/INR Monitor 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-2014-RN-01289-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-10
  • 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-01289-1
  • 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 certain cases an inratio & inratio2 pt/inr monitor system may provide an inr result that is clinically significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions.Br /br /further information has been published on the tga website at - http://www.Tga.Gov.Au/alert/alere-inratio-ptinr-monitor-system .
  • Action
    Alere is advising consumers and healthcare professionals of the additional warnings and precautions required when using the INRatio & INRatio2 PT/INR Monitor systems. Consumers are requested to consult their doctor to determine if any of the following conditions apply to them: - Anaemia (haematocrit < 30%) - chronic inflammatory conditions - severe infection - advanced stage cancer or end stage renal disease - any bleeding or unusual bruising. This action has beenclosed-out on 06/07/2016.

Device

Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)INRatio Test Strips Reference Numbers: HS0100071, HS0100139, HS099007EU, HS99007G1, HS099008EU, HS99008G1Multiple Product DescriptionsARTG Number: 216755INRatio2 Monitors Reference Numbers: HS0200431, HS200433SJM, HS200433SJMK, HS0200433Multiple Product DescriptionsARTG 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