Events

Retiro De Equipo (Recall) de IMMULITE 2000 SYSTEM - ESTRADIOL 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
    19549
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-11-02
  • 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 a small percentage of bead packs may intermittently fail to dispense a bead as a result of an issue with the bead pack plunger assembly. through the investigation of customer complaints and in collaboration with our supplier the frequency of occurrence has been determined as approximately 0.02%.

Device

IMMULITE 2000 SYSTEM - ESTRADIOL ASSAY
  • Modelo / Serial
    Model Catalog: L2KE22 (Lot serial: ALL); Model Catalog: L2KVB6 (Lot serial: ALL); Model Catalog: L2KVB2 (Lot serial: ALL); Model Catalog: L2KCL2 (Lot serial: ALL); Model Catalog: L2KRUB6 (Lot serial: ALL); Model Catalog: L2KRUB2 (Lot serial: ALL); Model Catalog: L2KTW6 (Lot serial: ALL); Model Catalog: L2KTW2 (Lot serial: ALL); Model Catalog: L2KT36 (Lot serial: ALL); Model Catalog: L2KT32 (Lot serial: ALL); Model Catalog: L2KTI6 (Lot serial: ALL); Model Catalog: L2KTI2 (Lot serial: ALL); Model Catalog: L2KDS2 (Lot serial: ALL); Model Catalog: L2KGB2 (Lot serial: ALL); Model Catalog: L2KCM6 (Lot serial: ALL); Model Catalog: L2KCM2 (Lot serial: ALL); Model Catalog: L2KCRP2 (Lot serial: ALL); Model Catalog: L2KON2 (Lot serial: ALL); Model Catalog: L2KTU2 (Lot serial: ALL); Model Catalog: L2KHB6 (Lot serial: ALL); Model Catalog: L2KHB2 (Lot serial: ALL); Model Catalog: L2KHPG6 (Lot serial: ALL); Model Catalog: L2KHPG2 (Lot serial: ALL); Model Catalog: L2KIP6 (Lot serial: ALL); Model Catalog: L2KIP2 (Lot serial:
  • Descripción del producto
    IMMULITE 2000 SYSTEM-ESTRADIOL ASSAY;IMMULITE 2000 SYSTEM- VITAMIN B12 ASSAY;IMMULITE 2000 SYSTEM- CALCITONIN ASSAY;IMMULITE 2000 RUBELLA QUANTITATIVE IGG;IMMULITE 2000 SYSTEM-TESTOSTERONE ASSAY;IMMULITE 2000 SYSTEM- TOTAL T3 ASSAY;IMMULITE 2000 SYSTEM- T
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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