Events

Rappel de Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)

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-2014-RN-00334-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-18
  • 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-2014-RN-00334-1
  • 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 a complaint for under-recovery of patient samples with the dimension vista csa flex reagent cartridge when whole blood samples are run from small sample container (ssc). investigations by siemens have confirmed that csa, as well as csae, under-recovers by 18% to 44% when whole blood samples are run from ssc.
  • Action
    Siemens is advising end users to cease using small Sample Containers when running whole blood samples with Dimension Vista CSA and CSAE assays. A review of previously reported results is recommended for cyclosprine samples run in Small Sample Containers. This action has been closed-out on 01/02/2016.

Device

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)
  • Modèle / numéro de série
    Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent CartridgeDimension Vista CSA:Catalogue Number: K4089Siemens Material Number: 10445139Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BBDimension Vista CSAE:Catalogue Number: K4108Siemens Material Number: 10445142Lot Numbers: 13157BC & 13429BDARTG Number: 182779
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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