Events

Rappel de UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. 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-2016-RN-01093-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-19
  • 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-2016-RN-01093-1
  • 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 identified the possibility of specimen mis-identification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id. results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:- the primary identifier is tube position id.- a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist.- the patient control sample is analysed using cassette presentation, but that tube does not contain a barcode-labelled specimen id or the label cannot be read.Upon analysis, the results from the analysed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file.
  • Action
    Beckman Coulter is advising users to ensure there are no pending or active test orders in the worklist before analysing a patient control with a Tube Position ID. Beckman Coulter is investigating the issue in order to determine a resolution.

Device

UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device...
  • Modèle / numéro de série
    UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600Reference Numbers: 629029, B24465, B24802, B68304 UniCel DxH 800Reference Number: B23858 All software versionsARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd