Events

Rappel de ADVIA Centaur XPT Systems. 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-2016-RN-00573-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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-2016-RN-00573-1
  • 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 healthcare diagnostics has identified an issue with the advia centaur xpt default setting for the daily maintenance task (or daily cleaning procedure) frequency. instruments may have the daily maintenance task frequency set to “as needed” instead of “daily”. not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results.
  • Action
    Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.

Device

ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10711433ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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