Events

Rappel de Dimension Clinical Chemistry System and Dimension Vista System. 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-00002-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-04
  • 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-00002-1
  • 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 diagnostics has determined that some lots of ammonia (amm) reagent used on both the dimension® and dimension vista® systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the instructions for use (ifu).
  • Action
    Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.

Device

Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical de...
  • Modèle / numéro de série
    Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).Dimension Clinical Chemistry SystemAssay: Ammonia AMMCatalogue No: DF119SMN: 10711991Lots: FB7152 (Exp 1/6/17), EB7180 (Exp 29/6/17), BA7194 (Exp 13/7/17), EA7223 (Exp 11/8/17), BA7250 (Exp 7/9/17)Dimension Vista SystemAssay: Ammonia AMMCatalogue No: K3119SMN: 10711992Lots: 16187BE (Exp 5/7/17), 16225BB (Exp 12/8/17), 16265AB (Exp 21/9/17)ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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