Events

Rappel de AQUIOS CL FLOW CYTOMETER

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
    49649
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2017-10-02
  • 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
    When aquios cl systems are connected to a laboratory information system (lis) the system may duplicate sample requests leading to sample mis-identification. for this to happen the following conditions must be met: -the aquios cl flow cytometer is connected to an lis and -the aquios cl system has the default test enabled and -host query is enabled in lis setup screen on system and -there are multiple cassettes in the autoloader and -the lis host query response is received in a brief time window before lis response timeout occurs. when all of these conditions are met a sample will follow two (2) paths of test request creation (lis and default test). all software versions (2.0 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the aquios cl are impacted by this issue.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

BECKMAN COULTER CANADA L.P.