Events

Rappel de ADVIA 1200, 1650, 1800 and 2400 Clinical 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-00933-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-05
  • 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-00933-1
  • 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 has confirmed that the affected advia chemistry systems will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. in cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. if a numerical result is generated with a flag, the ratio will be reported without a flag.
  • Action
    End users are requested to ensure that all ratio tests should be reviewed for flags prior to approving. Siemen's is developing a new version of software that will introduce a new flag for all ratio results that have a flag on a component test.

Device

ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device...
  • Modèle / numéro de série
    ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)Siemens Reference Number: CHSW 13-01ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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