Events

Retiro De Equipo (Recall) de ADVIA CENTAUR 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
    25695
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-01-12
  • 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 negative bias for advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur advia centaur xp and advia centaur xpt systems. in addition siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected. customers may continue to use calibrator a kit lots ending in 90 for the advia centaur systems ft3 t3 t4 and tup assays. internal investigations were performed using available ft4 lots. the investigation confirmed an overall negative bias when comparing calibrator a kit lots ending in 90 to previously released calibrator a kit lots ending in 89. in some instances the negative bias may cause euthyroid patient samples to result low and outside the reference interval listed in the instructions for use (ifu). quality control material and master curve material may result low and outside acceptable ranges.

Device

ADVIA CENTAUR SYSTEM - CALIBRATORS
  • Modelo / Serial
    Model Catalog: 04800735 (Lot serial: >10 LOT NUMBERS CONTACT MFR); Model Catalog: 04800646 (Lot serial: >10 LOT NUMBERS CONTACT MFR)
  • Descripción del producto
    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