Events

Rappel de Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( 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-00520-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-24
  • 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-00520-1
  • 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 has confirmed that there is potential for the vial volume of "in use" vista calibrators, controls or sample diluent to incorrectly revert to full volume when removed and reloaded.If vista vials revert to full volume, insufficient volume may result in the following:- calibrator vial – failed calibration- control vial – low out of range qc- sample diluent vial – auto-diluted results will flag with an above assay range error or a falsely elevated diluted result above the assay range will occur for the following methods: ctni, e2, or tsh.
  • Action
    Siemens is providing temporary work around instructions and is in the process of implementing Vista software version 3.6. Siemens is planning to send additional communication to customers when the software is available.

Device

Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in ...
  • Modèle / numéro de série
    Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10488224, 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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