Events

Rappel de UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)

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-2013-RN-00107-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-06
  • 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-00107-1
  • 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
    Improper tubing installing by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results. the reason for the customer mis-routing of instrument tubing was determined to be two fold:- the mechanical controls on the instrument were insufficient to prevent incorrect routing of the aspirate and dispense tubing.- the instructional drawings in the service documentation were difficult for the customer to understand.This recall action was not notified to the tga before it was initiated by beckman coulter australia.
  • Action
    Beckman Coulter Australia is advising that all affected systems were corrected with a new design that provided mechanical controls to reduce the potential for tubing installation errors. Also, updated service documentation with clearer instructions were distributed to affected customers.

Device

UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC ...
  • Modèle / numéro de série
    UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)Part numbers: 973100, A30260, A71456, A71457, A71460, A71461, A25285, A25288, A92060
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd