Events

Rappel de Beckman Coulter UniCel DxH 600 & DxH 800 Cellular Analysis Systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Beckman Coulter Inc.

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
    15774
  • Date de mise en oeuvre de l'événement
    2013-11-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Cause
    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).
  • Action
    Instructions for use to be updated

Device

Beckman Coulter UniCel DxH 600 & DxH 800 Cellular Analysis Systems
  • Modèle / numéro de série
    Model: Part Numbers: B23858 & 629029, Affected:
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc