Events

Rappel de AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (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-00277-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • 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-00277-1
  • 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
    A software error has been identified that has the potential to cause the reporting of erroneous patient results due to mis-identification by the au5800 system.This issue only occurs if all the following conditions apply:a) the system is in "measure 1" mode during analysis (sequential, barcode or rack number mode)b) a manual batch requisition is initiatedc) lis is running in real time for tri (test requesting information) received) when events b and c (above) occur simultaneously.
  • Action
    End users are advised of work around procedures to ensure erroneous results are not reported. Beckman Coulter will be addressing this issue in a future software update.

Device

AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and ...
  • Modèle / numéro de série
    AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (An in vitro diagnostic medical device (IVD))ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd