Events

Rappel de ACCESS SYSTEM - FREE T3 ASSAY

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
    15868
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-07
  • 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 determined through customer feedback and internal testing that the affected access free t3 reagent lots demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results therefore is expected to be maintained for all future lots. patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. additional assay performance characteristics are not affected. due to matrix differences qc values may not demonstrate a shift.

Device

ACCESS SYSTEM - FREE T3 ASSAY
  • Modèle / numéro de série
    Model Catalog: A13422 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    ACCESS SYSTEM - FREE T3 ASSAY;UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.