Events

Retiro De Equipo (Recall) de DIMENSION CHEMISTRY SYSTEM - TACR FLEX REAGENT

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
    101988
  • Clase de Riesgo del Evento
    II
  • 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
    There are confirmed customer complaints of low patient sample recovery with dimension tacr flex reagent cartridge lot bb4087 and its linked calibrator lot 3bd029. quality control (qc) materials have not exhibited recovery outside of the expected range. internal complaint testing versus our reference lc/ms method confirmed an average bias of -1.6 ng/ml [-2.1 nmol/l] across the assay range. individual patients particularly samples with lower tacr values (< 5 ng/ml [6.5 nmol/l]) may show more bias due to the typical precision of each methodology.

Device

DIMENSION CHEMISTRY SYSTEM - TACR FLEX REAGENT
  • Modelo / Serial
    Model Catalog: DF107 (Lot serial: DF107: LOT BB4087); Model Catalog: DC107 (Lot serial: ); Model Catalog: DF107 (Lot serial: ); Model Catalog: DF107 (Lot serial: FOR ALL); Model Catalog: DC107 (Lot serial: FOR ALL); Model Catalog: DF107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DF107: LOT BB4087)
  • Descripción del producto
    DIMENSION CHEMISTRY SYSTEM-TACR FLEX REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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