Events

Retiro De Equipo (Recall) de ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS

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
    136600
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-10-07
  • 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
    Siemens has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to certain lots may cause on average a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. due to the proportional bias the differences become greater as the concentration of dbil_2 increases. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory quality control may not detect this issue.

Device

ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Modelo / Serial
    Model Catalog: 10312279 (Lot serial: 680726D); Model Catalog: 10312279 (Lot serial: 680726C); Model Catalog: 10312279 (Lot serial: 680726B); Model Catalog: 10312279 (Lot serial: 680726A); Model Catalog: 10312279 (Lot serial: 680726)
  • Descripción del producto
    ADVIA CHEMISTRY SYSTEMS - CHEMISTRY CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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