Events

Rappel de UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - ANALYZER - CLASS II

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
    56429
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-01-28
  • 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
    The sample presentation unit ("spu") may push two sample racks instead of one into the sample presentation area when the gap between racks is obstructed with foreign material such as tape. beckman coulter has received a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. the first rack of the two was not scanned. this is referred to as a "pushed pair.".

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - ANALYZER - CLASS II
  • Modèle / numéro de série
    Model Catalog: 973100 (Lot serial: 973100); Model Catalog: 4773 (Lot serial: A64935); Model Catalog: 4771 (Lot serial: A64871); Model Catalog: A30260 (Lot serial: A30260); Model Catalog: A71461 (Lot serial: A71461); Model Catalog: 4768 (Lot serial: A59102)
  • Description du dispositif
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS II
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.