Events

Rappel de ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systems

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-00672-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-07-03
  • 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-00672-1
  • 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 have identified that the percent recovery for 1:10 diluted patient sample dilutions is lower than reported in the instructions for use (ifu). dilution of patient samples is primarily used to resolve results above the diagnostic range of the hcy assay.
  • Action
    Siemens is advising end users to ensure that 1:10 sample dilution testing is no longer carried out. The performance of 1:2 sample dilutions has been confirmed to meet the IFU recoveries and can continue to be tested. This action has been closed-out on 07/09/2016.

Device

ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP sy...
  • Modèle / numéro de série
    ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systemsMultiple Catalogue numbers and Lot numbers affectedARTG Number: 175075 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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