Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) 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
    135859
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-26
  • 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
    Manufacturer received customer complaints for falsely elevated advia chemistry lipase results as a result of carryover from cholesterol_c dldl and triglycerides reagents. manufacturer internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in high lipase outlier results. the results generated when this issue occurs are falsely elevated for a normal range lipase sample. customers have reported approximately a 25% positive bias while approximately a 12% positive bias was observed in-house. the issue may or may not be detected by quality controls depending on where a carryover incident occurs. if carryover occurs during qc analysis it will impact the qc result. if it does not occur during a qc analysis then the qc result will not be affected.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) ASSAY
  • Modelo / Serial
    Model Catalog: B01-4840-01 (Lot serial: ALL); Model Catalog: 01984894 (Lot serial: ALL)
  • Descripción del producto
    ADVIA 1200 CHEMISTRY SYSTEM-LIPASE (LIP) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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