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-00387-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-24
  • 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-00387-1
  • 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 a potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) assay on the advia centaur systems. (this only occurs when the syphilis assay immediately precedes the br assay on the advia centaur, advia centaur xp or advia centaur xpt systems.) syphilis interference may cause controls to recover low out of range for the advia centaur br assay. siemens evaluated br patient samples within the analytical measuring range and br samples above the analytical measuring range (> 450 u/ml) between 5,875 u/ml & 11,443 u/ml. advia centaur br patient samples below 221 u/ml are unaffected. advia centaur br patient samples above the analytical measuring range may recover on curve as low as 200 u/ml. a falsely low result during serial monitoring of treatment response when the true value is stable/increasing may lead to a delay in detection of cancer progression.Current & future lots of advia centaur systems br reagents are affected until implementation of a solution.
  • Action
    Siemens is requesting customers to refer to their recall notification letter to ascertain the ways their system is affected and to follow the appropriate instructions on how to correct their systems. Customers are advised to immediately contact their local Siemens Customer Care Centre or their local Siemens technical support representative, if they have received complaints of illness or adverse events associated with the products. Customers are further advised to review the recall notification letter with their medical director.

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 respectivelyAll Lot NumbersSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPTARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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