Events

Rappel de ACT 5DIFF SERIES HEMATOLOGY ANALYZER

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
    30894
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-06-21
  • 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 confirmed that the serial nameplate attached to rear of the affected devices does not include the nationally recognized testing laboratory (nrtl) certification graphic and therefore the affected devices do not meet the us and canadian occupational safety labeling requirements. this is a labeling error only as the safety of the product has been certified by the nrtl and otherwise meets the us and canadian occupational and safety requirements. the devices therefore are compliant with all ul/csa requirements and received the tuv certificates. the performance of the devices is not impacted.

Device

ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Modèle / numéro de série
    Model Catalog: 6605641 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV12038); Model Catalog: 6605641 (Lot serial: AV12038); Model Catalog: 175356 (Lot serial: AV07017); Model Catalog: 175356 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV14046); Model Catalog: 175356 (Lot serial: AV14046); Model Catalog: 6605641 (Lot serial: AV05025); Model Catalog: 6605641 (Lot serial: AV09024); Model Catalog: 175356 (Lot serial: AV09024)
  • Description du dispositif
    ACT 5DIFF SERIES HEMATOLOGY ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.