Events

Rappel de HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (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-00984-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-09-25
  • 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-00984-1
  • 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 determined that not all distributed lots would meet the performance criteria as currently described in the instructions for use (ifu) with respect to the analytical sensitivity. siemens are updating the labelling to better reflect the observed and potential range of assay performance with respect to this parameter (i.E less than and equal to 2.0 iu/ml).
  • Action
    Siemens is providing work around instructions for users to follow until the revised Instructions for Use (IFU) are released.

Device

HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an...
  • Modèle / numéro de série
    HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an in vitro diagnostic medical device (IVD))Catalogue Number: 06520528Siemens Material Number: 10283020Multiple lot numbers affectedARTG Number: 205090
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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