Retiro De Equipo (Recall) de cobas e 801 syringe plunger issue

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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The manufacturer has received complaints describing an issue with the syringe plunger on the cobas e 801 module prewash syringe assembly. investigations determined that the issue may also occur on the cobas e 801 module r1 or r2 reagent assembly. depending on the affected syringe, r1, r2 or prewash, liquids may not be pipetted correctly due to the syringe plunger being damaged. depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. during the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function.
  • Acción
    Product to be modified