Events

Retiro De Equipo (Recall) de Chemistry Analyser Module

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 Roche Diagnostics GmbH.

¿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
    21694
  • Fecha de inicio del evento
    2017-07-18
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    A case was reported, in which an operator suffered a blood injury (cut thumb) after attempting to remove the metal cover of the ultrasonic mixer 3 (usm 3). this injury occurred during routine maintenance when the thumb screws holding usm 3 cover were being loosened to remove the usm cover and thus allow access to the waterbath and allow replacement of the cuvettes. contact between the operator's thumb and the edge of the usm cover caused this injury.
  • Acción
    Manufacturer to issue advice regarding use

Device

Chemistry Analyser Module
  • Modelo / Serial
    Model: , Affected: cobas c501 and cobas c502 chemistry analyser modules.
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH