Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - DRUGS OF ABUSE CALIBRATOR

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
    24760
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-01-21
  • 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
    Manufacturer has determined that incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i lot 3jd018 for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values. internal investigation concluded that quality control results still recover within the manufacturer's ranges when using either the incorrect or corrected calibrator values. there is no change to the calibrator values for the advia chemistry systems theophylline 2 (theo_2) assay.

Device

ADVIA 1200 CHEMISTRY SYSTEM - DRUGS OF ABUSE CALIBRATOR
  • Modelo / Serial
    Model Catalog: 10376770 (Lot serial: 3JD018)
  • Descripción del producto
    ADVIA Chemistry Systems Drug Calibrator I
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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