Events

Rappel de Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnostic 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-2015-RN-00143-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • 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-2015-RN-00143-1
  • 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 is advising the users that it is releasing access 2 system software version 3.4.2 and access 2i (unicel dxc 600i system) software version 6.2.2 to address the reagent pack volume issues notification that was distributed august 13, 2010. the notification discussed the risks associated with assay reagent packs that were loaded incorrectly, or reagent packs that were inappropriately transferred between two systems (pack sharing). with these software versions, the new reagent pack monitoring feature enables the access 2 system pressure monitoring hardware to detect packs with insufficient volume, as well as packs that are improperly loaded or missing.
  • Action
    Beckman Coulter is providing customer-installable 3.4.2 or 6.2.2 software disc along with an information packet that describes the new reagent pack monitoring feature to all customers in Australia. This action has been closed-out on 20/06/2016.

Device

Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnos...

Manufacturer

Beckman Coulter Australia Pty Ltd