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
    43237
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2018-01-30
  • 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
    If the following sequence of events is followed it will result in sample mis-identification and erroneous results will be generated. the system will not identify or flag the erroneous results. - the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted places a specimen tube in single tube loader and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the "details" column on running screen changes to "prepping" for that sample. - user removes the first specimen tube and replaces with a different specimen tube. if another request is entered for the new specimen and the single-tube loader door is closed the new specimen tube will be prepared twice. both test requests will be processed with 2nd specimen tube. if another request is not entered for new specimen and the single-tube loader door is closed the new specimen tube will be prepared once. the first test request will be processed with 2nd specimen tube.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

BECKMAN COULTER CANADA L.P.