Events

Rappel de PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)

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-00648-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • 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-00648-1
  • 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 confirmed an overall average positive bias of approximately 20%-23% across the assay range relative to who 96/670 with the immulite systems psa assays. this positive bias is observed in patient values and the siemens tumor marker controls (tmco).
  • Action
    Siemens are advising users to discontinue use and discard any remaining kits. Replacement kits will be available in July 2013. Siemens is recommending a lookback period of two months of previous test results. For results that were recorded as abnormal, please notify the treating physician. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration.

Device

PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an ...
  • Modèle / numéro de série
    PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)Multiple Lot numbers affectedMultiple Catalogue numbers affectedAll kit lots released in February 2012.ARTG Number: 180971
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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