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
    71085
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-28
  • 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
    Beckman coulter has identified an incompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time this incompatibility may lead to: breaks in no foam cap assembly (pn a84827) cracks in no foam waste collector (pn a60007/a64665) seepage outside no foam tubing (pn's a10027 a10028 and a67123). this incompatibility does not affect no foam's ability to perform its function and there is no impact to patient results. cracks in the waste collector may stop instrument operation due to vacuum error and potentially lead to biohazardous waste exposure. cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam.

Device

UNICEL DXC 600
  • Modèle / numéro de série
    Model Catalog: 4764 (Lot serial: ALL); Model Catalog: 4772 (Lot serial: ALL); Model Catalog: 4773 (Lot serial: ALL); Model Catalog: 4767 (Lot serial: ALL); Model Catalog: 4771 (Lot serial: ALL); Model Catalog: 4768 (Lot serial: ALL); Model Catalog: B64130 (Lot serial: ALL)
  • Description du dispositif
    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS;UNICEL DXC 680I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 860I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 600I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS;UNICEL DXC 800 SYNCHRON CLINICAL S
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.