Events

Rappel de AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, 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-2013-RN-00402-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-07
  • 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-00402-1
  • 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 implemented a redesigned detergent tube, replacing the tubing with a more pliable material to allow for easier insertion to the detergent tank. new complaints that the joint connecting the tubing is disintegrating over time have been received. disintegration of the tubing/joint has the potential to result in detergent leaks.
  • Action
    Beckman Coulter has requested their customers to implement work around maintenance procedures until a new tubing design can be implemented. Customers are also requested to discontinue use of the analyser and contact Beckman Coulter immediately if a leak occurs.

Device

AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device...
  • Modèle / numéro de série
    AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device (IVD)(Customers with modifications AU2700-184, AU5400-190 Complete)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd