Events

Rappel de Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).

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-01117-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-24
  • 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-2016-RN-01117-1
  • 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 the concentrations for some of the cross reactants listed in the specificity section of the dimension opiates assay instructions for use and the cross-reactivity section of the dimension vista opiates assay instructions for use are incorrect. siemens has revised the concentrations, which will enable the correct interpretation on how cross reactants can affect test results. the instructions for use for the opiates assay will be updated with the correct concentrations when siemens completes their investigation of the issue.
  • Action
    Siemens is advising users to review the revised cross-reactant concentrations for Levallorphan, Levorphanol, Nalorphone and Oxycodone that are provided in the recall correspondence with their Medical Director. The decision to perform a look-back should be at the discretion of the Medical Director. Siemens will be updating the IFU with the revised concentrations once they have completed their investigation of the issue.

Device

Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).
  • Modèle / numéro de série
    Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).Assay Name: Dimension OpiatesCatalogue Number: DF93ASiemens Material Number: 10444923Assay Name: Dimension Vista OpiatesCatalogue Numbers: K5093 Siemens Material Number: 10445114All lots, including all future lots until the IFU is updatedARTG Number: 182221
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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