Events

Rappel de EasyLink Data Management System, all versions (used for connecting multiple IVD instruments to Laboratory Information System (LMS))

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 Ltd Diagnostics Division.

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-2013-RN-00893-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-21
  • 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-2013-RN-00893-1
  • 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
    Under certain conditions, the system may not perform as intended, causing the release of results to the laboratory information system (lis) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to lis.
  • Action
    End users are requested to determine if they are affected and to implement work around to ensure the issue does not occur. If affected, look back at previous results should be carried out at the discretion of the laboratory director. Software update is available to permanently fix the issue.

Device

EasyLink Data Management System, all versions (used for connecting multiple IVD instruments to La...
  • Modèle / numéro de série
    EasyLink Data Management System, all versions (used for connecting multiple IVD instruments to Laboratory Information System (LMS))Siemens Material Number: 10444799, 10444800 & 10487219
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA