Events

Rappel de ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. 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-00111-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-02-10
  • 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-00111-1
  • 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 determined through an internal investigation that some assays do not align with the representative data published in the instructions for use (ifu) for on-board stability, calibration frequency, and/or interference.
  • Action
    Siemens is requesting their customers to verify that the current IFU version for methods in use in the laboratory is being followed. Navigate to the Siemens Document Library for the current version of the IFU: https://www.healthcare.siemens.com/doclib. For on-board stability and calibration frequency changes, ensure that the ADVIA Chemistry system is programmed to reflect the changes indicated in the IFU. This action has been closed-out on 03/08/2016.

Device

ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical ...
  • Modèle / numéro de série
    ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical device (IVD)Multiple Siemens material numbersARTG number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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