Events

Retiro De Equipo (Recall) de Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Rad Laboratories 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-2014-RN-00856-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-01
  • 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-2014-RN-00856-1
  • 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
    Following two customers complaints reporting false resistance, we have identified a risk that amoxicillin+clavulanic acid disks could discharge during their use. the stability of amoxicillin + clavulanic acid combination might deteriorate over time in the conditions of routine use, even if following bio-rad storage recommendations (at 2-8°c with desiccant).
  • Acción
    To limit the risk of releasing false resistances results, Bio-Rad is requesting their customers to stop using the concerned lot and to destroy the remaining containers locally. This action has been closed-out on 02/06/2016.

Device

Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Amoxicillin + clavulanic acid 20 & 10 ìg discs. An in vitro diagnostic medical device (IVD).Catalogue Number: 66178Batch Number: 4D5612 ARTG Number: 192139
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd