Events

Rappel de Stratus CS Acute Care Diagnostics 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-00867-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-06-29
  • 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-00867-1
  • 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 has identified a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. the probability of occurrence is extremely unlikely and other factors such as previous results, patient presentation, and other diagnostic testing would initiate clinical questioning and reduce the potential for injury.
  • Action
    Siemens Healthcare is advising users of the following: 1. Do not use TestPaks that are due to expire within 48 hours, OR 2. Check Reagent Status to ensure all TestPaks in use have valid calibration expiry dates beyond the TestPak lot expiry date, AND 3. If the laboratory performs routine QC and if using a TestPak that is due to expire within 48 hours, ensure that scheduled QC is performed before running a test. Siemens Healthcare is currently developing software updates to address this issue and will be providing new information as it becomes available.

Device

Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).

Manufacturer

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