Events

Rappel de Dimension Vista 500 Intelligent Lab System and Dimension Vista 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 Healthcare Pty Ltd.

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-2017-RN-00347-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-14
  • 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-2017-RN-00347-1
  • 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
    There has been confirmation that in isolated cases when enzymatic creatinine (ecrea) is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ecrea result. whilst it is understood that users routinely run quality control (qc) after system maintenance, it is particularly important to run ecrea qc after the probe test to identify a potentially elevated ecrea result. (please note that this information applies only to laboratories processing enzymatic creatinine (ecrea: enzymatic creatinine cat no. k1270a, smn 10700444) after the implementation of the automated acid clean (acln) maintenance routine).
  • Action
    Siemens is recommending affected users to adhere to the following steps: 1) replace the appropriate reagent probe (only if the ECREA reagent probe has not been replaced since the activation of ACLN) 2) process QC which includes ECREA immediately after routinely scheduled Off Peak Activities including Probe Test; and 3) contact Siemens Customer Care Centre IF, after replacement of reagent probe, users experience elevated ECREA QC results directly after Off Peak Activities which includes the Probe Test or after manually processing the Probe Test.

Device

Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in...
  • Modèle / numéro de série
    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD).Dimension Vista 500 Intelligent Lab System Siemens Material Number (SMN) 10488224Dimension Vista 1500 Intelligent Lab SystemSiemens Material Number (SMN) 10444802ARTG number: 174699
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA