Events

Rappel de UNICEL DXC 600

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
    53044
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-07-17
  • 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 identified a failure of the unicel dxc ise tubing (lines 11 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticizer and the ise reference reagent. the supplier's change in plasticizer was a result of a move to a phthalate-free tubing material based on new environmental regulations. as a result a slowforming non-microbial white material may appear inside the tubing. observed symptoms of the presence of the white material can include suppressed ion specific electrode (ise) quality control and patient results ise calibration failures and detached tubing lines 25 or 26 due to obstruction of flow. current investigation suggests it is highly unlikely that incorrect results will be generated.

Device

UNICEL DXC 600
  • Modèle / numéro de série
    Model Catalog: 4764 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4773 (Lot serial: 3048); Model Catalog: 4773 (Lot serial: 4282); Model Catalog: 4767 (Lot serial: >10 numbers contact mfg.); Model Catalog: 4771 (Lot serial: 4036); Model Catalog: 4768 (Lot serial: 4143); Model Catalog: 4768 (Lot serial: 2788); Model Catalog: 4768 (Lot serial: 3563)
  • Description du dispositif
    UniCel DxC 600 SYNCHRON Clinical Systems
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.