Events

Rappel de Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. 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-2015-RN-01204-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-09
  • 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-01204-1
  • 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
    During internal testing, it was determined that the software for various dxh systems allows for the creation of multiple orders with the same specimen identification (id), but a different patient identification when manually editing pending orders at the system manager.This issue does not occur for edits of released results or for test orders requested through host transmission.There is a possibility of sample misidentification and the release of erroneous results.
  • Action
    Beckman Coulter is advising users not to edit the Specimen ID for a pending test order at the System Manager's Worklist. A software upgrade will be available to correct the issue. This action has been closed out on 13 Jun 2017.

Device

Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diag...
  • Modèle / numéro de série
    Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD)Unicel DxH 800 Coulter Cellular Analysis SystemReference Numbers: 629029, B24465 and B24802Software version: 3.0.2.0Unicel DxH SMS Coulter Cellular Analysis SystemReference Numbers: 775222Software version: 3.0.2.0Unicel DxH 600 Coulter Cellular Analysis SystemReference Numbers: B23858Software version: 1.1.1.0ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd