Events

Rappel de Dimension Vista 500 and 1500 Intelligent Lab 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 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-2015-RN-00430-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-20
  • 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-2015-RN-00430-1
  • 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
    Issue 1: samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable. issue 2:complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronisation during the automatic removal of reagent cartridges from reagent server 2 to waste a container. in the extremely unlikely circumstance that this issue occurs, a flag will be generated for the majority of assays. however, there is the potential to produce unflagged erroneous but believable results for some assays.
  • Action
    Users are provided with temporary workarounds in the customer letter. Siemens will be providing corrections for the issues in a future Vista software version. Review of previously generated results due to this issue is at the discretion of laboratory. This action has been closed-out on 26/08/2016.

Device

Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD)Software version: 3.6.1, 3.6.1_MU3p and 3.6.1SP1ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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