Events

Rappel de Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). 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 Siemens Ltd Diagnostics Division.

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-00151-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-15
  • 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-00151-1
  • 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
    Siemens investigations have confirmed that with sysmex cs-2000i or sysmex cs-2100i systems the last (up to 4) measurements out of a thromborel s vial may be erroneously prolonged (longer pt sec, lowered % of norm, increased inr). this may occur if the reagent in the vial is nearly used up and has been placed on board of the sysmex cs-2000i/cs-2001i systems for more than 4 hours.
  • Action
    End users are being advised to mix reagent carefully every 4 hours. Review of patient results should be carried out at the discretion of the laboratory director. Siemens representative will contact the affected customers as soon as a technical solution is available.

Device

Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determin...
  • Modèle / numéro de série
    Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). An in vitro diagnostic medical device (IVD)Siemens Catalogue & Material Numbers: OUHP295 / 10446442 & OUHP495 / 10446445Sysmex Japan Catalogue & Material Numbers: OUHP295J / 10469932 & OUHP495J / 10469933ARTG Numbers: 178501 & 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA