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
    132703
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-02-16
  • 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 healthcare diagnostics has confirmed a lot to lot bias with calibrator e kit for the advia centaur testosterone assay. internal investigation demonstrates: -an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. -an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. -the positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the performance of the testosterone assay on the advia centaur cp is not affected. calibrator e is also used for calibration of the advia centaur systems cortisol and progesterone assays however the performance of these assays is not affected.

Device

ADVIA CENTAUR CP SYSTEM - CALIBRATOR
  • Modelo / Serial
    Model Catalog: 04636889 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 04634762 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 04634452 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    ADVIA CENTAUR CP SYSTEM-CALIBRATOR;ADVIA CENTAUR SYSTEM-CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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