Events

Retiro De Equipo (Recall) de ACCESS SYSTEM - FREE T3 ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    15868
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-07
  • 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
    Beckman coulter has determined through customer feedback and internal testing that the affected access free t3 reagent lots demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results therefore is expected to be maintained for all future lots. patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. additional assay performance characteristics are not affected. due to matrix differences qc values may not demonstrate a shift.

Device

ACCESS SYSTEM - FREE T3 ASSAY
  • Modelo / Serial
    Model Catalog: A13422 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    ACCESS SYSTEM - FREE T3 ASSAY;UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - FREE T3 ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC