Events

Retiro De Equipo (Recall) de ACTIN FSL ACTIVATED PTT REAGENT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    20599
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-15
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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
  • Descripción del producto
    DADE ACTIN FSL ACTIVATED PTT REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC