Events

Rappel de Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro 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-2012-RN-01048-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2012-11-01
  • 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-2012-RN-01048-1
  • 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 received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension® alp method. siemens' internal investigation has confirmed that the activity of the dimension vistaalp cal, kc330, changes as the product ages and contributes to this correlation slope bias as well as accuracy shift. the magnitude of the accuracy shift is the same for qc and patient samples and does not exceed the allowable bias for the dimension vista alp assay. in order to ensure better correlation and accuracy, the shelf life for the dimension vista alp cal has been decreased from 12 months to 4 months.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device...
  • Modèle / numéro de série
    Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)Catalogue Number: KC330Siemens Material Number: SMN 10445181Lot number recalled : 2AD052Lot numbers whose shelf life will be reduced: 2GD011 and higherARTG Number: 181688
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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