Events

Retiro De Equipo (Recall) de IMMULITE SYSTEM - THYROGLOBULIN ASSAY

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
    15451
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-12-18
  • 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 through internal investigation that the immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays listed in the above table are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results on the assays listed above. the instructions for use (ifu) currently do not list biotin as a potential interferant.

Device

IMMULITE SYSTEM - THYROGLOBULIN ASSAY
  • Modelo / Serial
    Model Catalog: LKTY1 (Lot serial: N/A); Model Catalog: LKCE1 (Lot serial: N/A); Model Catalog: L2KUN6 (Lot serial: N/A); Model Catalog: L2KFO6 (Lot serial: N/A); Model Catalog: L2KFO2 (Lot serial: N/A); Model Catalog: LKBR1 (Lot serial: N/A); Model Catalog: LKEPN1 (Lot serial: N/A); Model Catalog: L2KGA2 (Lot serial: N/A); Model Catalog: LKMB1 (Lot serial: N/A); Model Catalog: L2KOP2 (Lot serial: N/A); Model Catalog: L2KBR2 (Lot serial: N/A); Model Catalog: LKGA1 (Lot serial: N/A); Model Catalog: L2KMB2 (Lot serial: N/A); Model Catalog: LKVB1 (Lot serial: N/A); Model Catalog: L2KEPN6 (Lot serial: N/A); Model Catalog: LKOP1 (Lot serial: N/A); Model Catalog: L2KHC2 (Lot serial: N/A); Model Catalog: L2KCE2 (Lot serial: N/A); Model Catalog: L2KCE6 (Lot serial: N/A); Model Catalog: L2KTY2 (Lot serial: N/A); Model Catalog: L2KEPN2 (Lot serial: N/A)
  • Descripción del producto
    IMMULITE SYSTEM- THYROGLOBULIN ASSAY;IMMULITE SYSTEM- CEA ASSAY;IMMULITE 2000 SYSTEM-3GALLERY SPECIFIC IGE ASSAY;IMMULITE 2000 SYSTEM- FOLIC ACID ASSAY;IMMULITE 1000 SYSTEM- THYROGLOBULIN ASSAY;IMMULITE SYSTEM- BR-MAT. MARKER CA 15.3 ASSAY;IMMULITE SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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