Events

Rappel de Dimension Enzyme II Calibrator (used with Dimension clinical chemistry 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-2016-RN-00661-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-19
  • 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-00661-1
  • 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 positive shift of patient and qc results when the alti assay is calibrated with the affected dimension enzyme ii calibrator lots. internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. there is no risk to patients however there may be a delay in results.
  • Action
    Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagn...
  • Modèle / numéro de série
    Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)Product Code: ENZ II CALCatalogue Number: DC143Siemens Material Number (SMN): 10476170Multiple Lot Numbers and Expiry Dates affectedARTG Number: 181688
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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