Events

Retiro De Equipo (Recall) de ADVIA CENTAUR XP SYSTEM - 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
    21197
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-09-29
  • 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
    Calibrator e is used for calibration of the advia centaur systems cortisol progesterone and testosterone assays. siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves. patient serum samples evaluated with the advia centaur cortisol assay and calibrated with calibrator e kit lots listed in table 1 demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. patient serum samples evaluated with the advia centaur systems progesterone assay and calibrated with calibrator e kit lots ending in 38 and 39 demonstrate a positive bias with samples above 30 ng/ml. the average positive bias on the advia centaur/advia centaur xp is 20% with a maximum bias of 39%. the average positive bias on the advia centaur cp is 17% with a maximum bias of 35%. the advia centaur systems testosterone assay is not affected by this correction.

Device

ADVIA CENTAUR XP SYSTEM - CALIBRATORS
  • Modelo / Serial
    Model Catalog: 04634762 (Lot serial: >10 contact mfg.); Model Catalog: 04634452 (Lot serial: >10 contact mfg.); Model Catalog: 04636889 (Lot serial: >10 contact mfg.)
  • Descripción del producto
    Advia Centaur XP System - Calibrator E
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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