Events

Rappel de Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent

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
    20362
  • Date de mise en oeuvre de l'événement
    2016-07-06
  • 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
    An iincompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery has been identified., dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time, this incompatibility may lead to:, - breaks in no foam cap assembly, - cracks in no foam waste collector; and, - seepage outside no foam tubing, this issue may lead to cracks in the waste collector which may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent
  • Modèle / numéro de série
    Model: B64130, Affected: All lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc