Events

Rappel de TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP

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-2016-RN-00603-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-12
  • 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-2016-RN-00603-1
  • 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 laboratory diagnostics has confirmed that all in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate = 10% change in results. the biotin level in a general population is approximately 0.3 to 1.0 ng/ml (1.2 to 4.3 nmol/l).The biotin interference is proportionate across tni concentrations; therefore, the ability of the assay to detect serial increases or decreases of tni is maintained.
  • Action
    Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained. A review of previously generated results is at the discretion of the Laboratory Director.

Device

TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An...
  • Modèle / numéro de série
    TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD)Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP Catalogue Numbers: 02789602, 02790309Siemens Material Numbers (SMN): 10317708, 10317709Multiple Lot Numbers affectedARTG Number: 175197
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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