Events

Rappel de Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (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-2012-RN-01160-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • 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-2012-RN-01160-1
  • 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 identified a potential problem in two pulley drive components in the mixer pulley assemblies of these systems.It has been determined that in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. beckman coulter is in the process of producing replacement components and will be installing them in every access/access 2 immunoassay, synchron lxi 725 clinical, and unicel dxc 6001 synchron access clinical system in the field.
  • Action
    Beckman Coulter is providing work around instructions to mitigate the risk and replacing the mixer pulley assemblies to permanently fix the problem.

Device

Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel ...
  • Modèle / numéro de série
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd