Events

Rappel de UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. 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-01021-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-01
  • 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-01021-1
  • 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
    An internal investigation indicates that specific lots of check valves used in several locations within the dxh 800 and dxh 600 systems may fail. a failure may result in an air or liquid leak at the vcs waste chamber or probe waste chamber.
  • Action
    End users are advised that if they experience a "Vent/overflow chamber detected overflow" error message, the three samples prior to the error message must be reviewed. Physical contact with leaks should be avoided by continuing to use protective equipment. A service representative will contact each customer to schedule an on-site visit for check valve inspection of any affected valves.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medic...
  • Modèle / numéro de série
    UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)UniCel DxH 800 Coulter Cellular Analysis SystemProduct Number: 629029UniCel DxH 600 Coulter Cellular Analysis SystemProduct Number: B23858
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd