Events

Rappel de ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    154472
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-03-13
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Beckman coulter has confirmed through internal investigation that the access reaction vessel (rv) lots listed fail to meet a specification for outside diameter on the open ended side of the rv. - the rv lots listed may cause aliquot vessel (av) shuttle motion errors when they are loaded onto the unicel dxc 600i synchron access clinical system through the closed tube aliquotter (cta). there is no impact to patient results. - internal testing did not demonstrate shuttle motion errors on the access 2 standalone system.

Device

ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
  • Modèle / numéro de série
    Model Catalog: 81600N (Lot serial: B16113TA); Model Catalog: 81600N (Lot serial: B161134H); Model Catalog: 81600N (Lot serial: B161134E); Model Catalog: 81600N (Lot serial: B161233V); Model Catalog: 4767 (Lot serial: B161035D); Model Catalog: 4767 (Lot serial: B161134E); Model Catalog: 81600N (Lot serial: B161035D); Model Catalog: 4767 (Lot serial: B16113TA); Model Catalog: 4767 (Lot serial: B161233V); Model Catalog: 4767 (Lot serial: B161134H)
  • Description du dispositif
    ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3;UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER;ACCESS SYSTEM ACCESS 2 ANALYZER - CLASS 2;ACCESS2 IMMUNOASSAY SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.