Events

Rappel de ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. 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-2015-RN-00739-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-08-12
  • 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-00739-1
  • 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 confirmed that urea nitrogen reagent kit lots listed and urea nitrogen concentrated reagent kit lots listed for use on advia 1200, 1650, 1800, 2400 and xpt chemistry systems demonstrate an increased incidence of calibration failures. results cannot be generated by the system when calibration fails. failed calibration may lead to a slight delay in results until a replacement or suitable material to perform the calibration verification is obtained. the risk to health is negligible.
  • Action
    Siemens is advising users that if they experience this issue, to request unaffected replacement product. Siemens is not recommending a review of previously generated results. This action has been closed-out on 07/09/2016.

Device

ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnos...
  • Modèle / numéro de série
    ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)Urea Nitrogen AssayCatalogue Number: 03040257Lot Numbers: 321973, 333872Expiry date: 2015-11Lot Number: 348126Expiry date: 2016-06Urea Nitrogen Concentrated AssayCatalogue Number: 06860558Lot Number: 321967 Expiry date: 2015-11Lot Number: 332365 Expiry date: 2016-03ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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