Events

Retiro De Equipo (Recall) de OriGen Syringe DMSO (Used for Research Use Only)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Diagnostic Solutions Pty Ltd.

¿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
    RC-2012-RN-01041-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01041-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Pure dmso is reacting with syringe polymers and degrading during storage and dmso begins to show a light yellow color. purity has dropped from 99.9% to 99.6% after six months in storage.This recall action was not notified to the tga before it was initiated by diagnostic solutions pty ltd.
  • Acción
    The sponsor is asking users to quarantine and remove affected product and is supplying an alternative syringe until a replacement is available.

Device

OriGen Syringe DMSO (Used for Research Use Only)
  • Modelo / Serial
    OriGen Syringe DMSO (Used for Research Use Only)Multiple part numbers and lot numbers affected
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd