Events

Rappel de ADVIA Centaur BR Assay (50 and 250 tests). 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 Healthcare Pty Ltd.

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-2017-RN-00389-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-27
  • 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-2017-RN-00389-1
  • 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
    There is confirmation that the advia centaur br (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit. when diluted, some samples over-recover the expected neat value by greater than 120%. dilution of samples with results greater than the analytical measuring range for the advia centaur br (ca 27.29) assay may be important for serial measurements during treatment.
  • Action
    Siemens is requesting users to discontinue dilution of samples using the ADVIA Centaur systems BR (CA 27.29) with Multi-Diluent 1 kit lots ending in 2577 and future lots of Multi-Diluent 1 until further notice. Users are advised to contact their local Siemens Customer Care Centre or their local Siemens technical support representative if they receive any complaints of illness or adverse events associated with the affected products.

Device

ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectivelySiemens Material Numbers (SMN): 10333349 and 10334837 respectivelyLots ending in 2577 and all future lotsSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CPARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA