Events

Retiro De Equipo (Recall) de AQUIOS CL Flow Cytometry System

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
    22097
  • Fecha de inicio del evento
    2017-12-05
  • 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
    The manufacturer is advising that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis-identification., this is an updated notification in follow-up to the previous communication received (dated 16 october 2017) concerning duplicate sample requests leading to sample mis-identification when using the aquios cl systems connected to a laboratory information system (lis). this important information needs immediate attention. the information replaces the instructions in the original notification dated 16 october 2017.
  • Acción
    Manufacturer to issue advice regarding use

Device

AQUIOS CL Flow Cytometry System
  • Modelo / Serial
    Model: , Affected: software versions (2.0, 2.0.1 and 2.1)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc