Events

Retiro De Equipo (Recall) de Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems

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
    14153
  • Fecha de inicio del evento
    2013-01-31
  • 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
    Improper tubing installation by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results., note - this matter was initiated in 2011 but was not advised as a recall action at the time. information received in retrospect following an audit of the manufacturer's capa files.
  • Acción
    Product to be modified

Device

Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems
  • Modelo / Serial
    Model: Models: DxI 800, DxI 600, DxC 660i, 680i, 860i, 880i, Affected: Specified serial number ranges
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc