Events

Retiro De Equipo (Recall) de Beckman Coulter Access Free T3 reagent

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Beckman Coulter Inc.

¿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
    20295
  • Fecha de inicio del evento
    2016-06-21
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    Specific lots manufactured post june 2015 of the access free t3 reagent demonstrate an upward shift in patient results., patient sample results will shift upward by approximately 10.4% 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.
  • Acción
    Manufacturer to issue advice regarding use

Device

Beckman Coulter Access Free T3 reagent
  • Modelo / Serial
    Model: A13422, Affected: Lot Nos: multiple (all lots manufactured post June 2015)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc