Events

Rappel de Beckman Coulter UniCel DxI and DxC Access Immunoassay 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
    14153
  • Date de mise en oeuvre de l'événement
    2013-01-31
  • 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
    Improper tubing installation by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results., note - this matter was initiated in 2011 but was not advised as a recall action at the time. information received in retrospect following an audit of the manufacturer's capa files.
  • Action
    Product to be modified

Device

Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems
  • Modèle / numéro de série
    Model: Models: DxI 800, DxI 600, DxC 660i, 680i, 860i, 880i, Affected: Specified serial number ranges
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc