Events

Retiro De Equipo (Recall) de IMMULITE SYSTEM - ANTI-TG AB

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
    64415
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-03-24
  • 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 that the intra-assay and inter-assay precision of the immulite/immulite 1000 and immulite immulite 2000 xpi anti-tg ab assays does not align with the representative data published in the instructions for use (ifu). siemens has conducted a "verification of precision performance" study to assess precision. while the concentrations did not exactly match those published in the ifu the study provides verification that the current precision performance is not in line with the ifu.

Device

IMMULITE SYSTEM - ANTI-TG AB
  • Modelo / Serial
    Model Catalog: LKTG1 (Lot serial: 244); Model Catalog: L2KTG6 (Lot serial: 567); Model Catalog: L2KTG2 (Lot serial: 567); Model Catalog: L2KTG6 (Lot serial: 565); Model Catalog: L2KTG2 (Lot serial: 565); Model Catalog: L2KTG6 (Lot serial: 560); Model Catalog: L2KTG2 (Lot serial: 560); Model Catalog: L2KTG6 (Lot serial: 577); Model Catalog: L2KTG2 (Lot serial: 577); Model Catalog: L2KTG6 (Lot serial: 574); Model Catalog: L2KTG2 (Lot serial: 574); Model Catalog: L2KTG6 (Lot serial: 572); Model Catalog: L2KTG2 (Lot serial: 572); Model Catalog: L2KTG6 (Lot serial: 569); Model Catalog: L2KTG2 (Lot serial: 569); Model Catalog: L2KTG6 (Lot serial: 562); Model Catalog: L2KTG2 (Lot serial: 562); Model Catalog: L2KTG6 (Lot serial: 566); Model Catalog: L2KTG2 (Lot serial: 566); Model Catalog: L2KTG6 (Lot serial: 564); Model Catalog: L2KTG2 (Lot serial: 564); Model Catalog: LKTG1 (Lot serial: 245)
  • Descripción del producto
    Immulite System-Anti-TG AB
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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