Retiro De Equipo (Recall) de ADVIA 560 HEMATOLOGY ANALYZER

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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Siemens has identified that software version 1.4.2133 does not trigger the following flags: - the w warning flag for detecting small sample volumes when using the international software configuration. if there is not enough sample volume of the patient's blood when the sample is run results may be lower than expected. this can occur if the required sample volume as defined in the advia 560 hematology system operator's guide is not followed. - the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp) respectively. the results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. as defined in the advia 560 hematology system operator's guide the immature granulocytes and atypical lymphocyte morphology flags should be raised when the presence of morphologically abnormal cells is suspected indicating that a manual count on a stained smear needs to be performed.


  • Modelo / Serial
    Model Catalog: 11170842 (Lot serial: S020099)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source