Events

Rappel de Dimension Vista Chemistry 3 Calibrator. 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-2016-RN-00236-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-03
  • 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-00236-1
  • 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 received complaints of “calibrator insert missing” alerts on the affected dimension vista chemistry 3 calibrator. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalogue number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label, the “calibrator insert missing” error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.
  • Action
    Siemens is advising users to use the re-printing options in the Vista system to re-print the affected barcodes. A review of previously generated results is at the discretion of the laboratory director.

Device

Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)Catalogue number: KC130ASiemens Material Number: 10711579Lot Number: 5MD004ARTG number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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