Events

Rappel de Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical 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 Beckman Coulter Australia 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-2014-RN-01087-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-10
  • 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-2014-RN-01087-1
  • 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
    Beckman coulter has determined that the access 2 console pc (b23083) may experience an “mfc exception” error during normal operation. if this error occurs, the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a “0==itubescancount” event. if the ui is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same “mfc exception” error will occur. the access 2 console pc ui error can cause a delay in reporting of results, but will not cause erroneous results.
  • Action
    Beckman Coulter service representative will contact affected customers and schedule a service visit to modify their Console PC. In the interim, customers are advised to continue operating their systems normally and contact Beckman Coulter Customer Support Centre if the error occurs. This action has been closed-out on 20/04/2017.

Device

Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON A...
  • Modèle / numéro de série
    Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). An in vitro diagnostic medical device (IVD)Ref.: B23083 (small PC with silver faceplate)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd