Events

Rappel de Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. 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-01297-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-05
  • 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-01297-1
  • 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 received complaints regarding variability in recovery of qc and patient results with the dimension vista csa flex reagent cartridge lots 12300bb, 12318bb, and 13011bb. investigation by siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with csa concentrations below 125 ng/ml. daily qc checks can detect performance variations in this assay.
  • Action
    Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a review of previously generated results is at the discretion of the laboratory.

Device

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medic...

Manufacturer

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