Events

Rappel de ACTIN FSL ACTIVATED PTT REAGENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    20599
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-12-15
  • 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 the reagent is used to monitor the effectiveness of unfractionated heparin therapy or oral anticoagulants there may be an erroneous drift of results with a higher than the clincally acceptable limits of heparin samples. the increased heparin sensitivity may lead to longer activated partial thromboplastin times (aptt) leading to inappropriately decreasing anticoagulant dosage. inappropriate reduction of anticoagulation increase the risk of thromboembolism.

Device

ACTIN FSL ACTIVATED PTT REAGENT
  • Modèle / numéro de série
    Model Catalog: B4219-2 (Lot serial: 537374); Model Catalog: B4219-1 (Lot serial: 537374); Model Catalog: B4219-2 (Lot serial: 537366); Model Catalog: B4219-1 (Lot serial: 537366); Model Catalog: B4219-2 (Lot serial: 537365A); Model Catalog: B4219-1 (Lot serial: 537365A); Model Catalog: B4219-2 (Lot serial: 537365); Model Catalog: B4219-1 (Lot serial: 537365); Model Catalog: B4219-2 (Lot serial: 537362A); Model Catalog: B4219-1 (Lot serial: 537362A); Model Catalog: B4219-2 (Lot serial: 537362); Model Catalog: B4219-1 (Lot serial: 537362); Model Catalog: B4219-2 (Lot serial: 537360A); Model Catalog: B4219-1 (Lot serial: 537360A); Model Catalog: B4219-2 (Lot serial: 537360); Model Catalog: B4219-1 (Lot serial: 537360); Model Catalog: B4219-1 (Lot serial: 537374A); Model Catalog: B4219-2 (Lot serial: 537374A); Model Catalog: B4219-1 (Lot serial: 547301); Model Catalog: B4219-2 (Lot serial: 547301); Model Catalog: B4219-1 (Lot serial: 547301A); Model Catalog: B4219-2 (Lot serial: 547301A); Model Catalog: B4219-2
  • Description du dispositif
    DADE ACTIN FSL ACTIVATED PTT REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC