Events

Rappel de UniCel DxH 600 & 800 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-2013-RN-01277-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-29
  • 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-01277-1
  • 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
    Update: beckman coulter's investigation has shown that the dxh cleaner were the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:- flow cell clogs (::::)- ls offset errors during daily check or control analysis- high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters- system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs)the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.
  • Action
    Update: Beckman Coulter is requesting their customers to discard the affected lot of DxH Cleaner. Laboratories can discontinue the additional flush flow cell and cleaning actions. Beckman Coulter is recommending users perform a Flush Flow Cell, Extended Cleaning and perform a routine shutdown at least daily. A permanent fix will be implemented when available.

Device

UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600 Coulter Cellular Analysis SystemPart Number: B23858UniCel DxH 800 Coulter Cellular Analysis SystemPart Number: 6290029
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd