Events

Rappel de ADVIA Chemistry 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 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-2013-RN-01158-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-11
  • 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-2013-RN-01158-1
  • 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
    When the system switches from the primary reagent pack to the back-up reagent pack, the software may result in the auto-calibration or qc to utilise the incorrect values for the blank and standard. the systems should not pass calibration and qc, however, the software version affected may allow the system to pass calibration and qc. this may result in a shift in patient results which can be observed through patient trending.
  • Action
    A software upgrade will be implemented for ADVIA systems 1800 and 2400 as a permanent fix. As the ADVIA 1650 is planned to be made obsolete effective March 2014 the software update has not been designed for this device. Siemens is providing users with work around instructions to follow as an interim measure. A review of previously generated results is at the discretion of the laboratory director. Thia action has been closed on 28/01/2016

Device

ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)ADVIA 1650Software versions: V3.52, V4.01ADVIA 1800Software version: V2.01ADVIA 2400Software version: V4.01Siemens Reference Number: CHSW 13-03ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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