Events

Rappel de AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. 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-2017-RN-00476-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-20
  • 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-2017-RN-00476-1
  • 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 confirmed that the export feature located in the results area of the aquios system software is not correctly exporting tetra combo crd files. upon import of the exported file to another aquios workstation, two individual files will be generated in the results tab rather than one combo file. the data and results on the acquisition system are not impacted. the possibility for erroneous results will occur under the following sequence of events:- using the export button to export a tetra combo crd file from the acquisition system; and- importing the data into a different system with a highly populated database; and - moving a region in any of the plots will generate erroneous results upon recalculation of the data.
  • Action
    Beckman Coulter will be addressing the issue in a subsequent software release. In the interim, Beckman Coulter is advising users to not use the Export button located in the Results area to export Tetra Combo CRD files and to export the files using the export icon, which exports the run displayed on the screen. For further instructions, users should refer to the AQUIOS Instructions for use, PN B21896 AD, Chapter 6- Data Review.

Device

AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medica...
  • Modèle / numéro de série
    AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medical device (IVD)Reference Number: B30166ARTG Number: 208574
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd