Events

Rappel de CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. 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 Roche Diagnostics Australia Pty Limited.

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-00415-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-09
  • 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-00415-1
  • 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
    Roche has discovered that in rare cases (<0.00015%) an “error 6” may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. in such patients inr values could be extremely high (>10 inr). the coaguchek displays the various codes when it suspects there could be a problem with the actual measurement of your inr. "error 6” when shown in the display represents alerts to a number of issues with the testing.
  • Action
    In the event of an "error 6" end users are advised to repeat the test and if the error continues contact their physician immediately. The package insert for the CoaguChek XS PT strips will be updated to contain this information. For more information, please see http://www.tga.gov.au/safety/alerts-device-coaguchek-inr-monitors-130516.htm .

Device

CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)Material numbers: 04796179001, 04811500001, 04963733001, 06505597001, 04800842190, 05864640001, 06505589001, 06644511001, 05530199190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited