Events

Retiro De Equipo (Recall) de ADVIA CENTAUR CP SYSTEM - 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
    127762
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-07-03
  • 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
    The high calibrator for calibrator a lot ca77 is under-recovering to the assigned target for the advia centaur total t4 assay. internal investigations showed that the average bias of the high calibrator-to-target is -20% with an observed range of bias from -21% to -19%. the under-recovery of the high calibrator is leading to an elevated response in the high end of the total t4 assay which may be reflected in level 3 quality controls (15.8ug/dl for biorad lyphochek control level (40243)) being out of range high. internal investigations showed that the average bias of the level 3 control-to-target is 16% which had an observed range of bias from 10% to 20%.

Device

ADVIA CENTAUR CP SYSTEM - CALIBRATOR
  • Modelo / Serial
    Model Catalog: 04800840 (Lot serial: 90705A77); Model Catalog: 04800735 (Lot serial: 90705A77); Model Catalog: 04800735 (Lot serial: 90669A77); Model Catalog: 04800840 (Lot serial: 90669A77); Model Catalog: 04800840 (Lot serial: 89983A77); Model Catalog: 04800735 (Lot serial: 89983A77)
  • Descripción del producto
    ADVIA CENTAUR CP SYSTEM-CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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