Events

Retiro De Equipo (Recall) de Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Origio Australasia 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-2016-RN-01552-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-06
  • 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-2016-RN-01552-1
  • 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
    Origio a/s has received two complaints regarding what appear to be particles, objects or growth in two bottles of the media. the media showed evidence of particulate matter, cloudiness, and was mis-coloured. to eliminate the risk of microbial contamination, art-1023, lot number 16280126 is being recalled.
  • Acción
    Origio is advising users to return unused affected product. Origio will provide either replacement stock or issue credit for returned unused stock. This action has been closed-out on 09/06/2017.

Device

Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)
  • Modelo / Serial
    Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium)Product Code: ART-1023Lot Number: 16280126Expiry Date: 14 July 2017ARTG Number: 151263
  • Manufacturer
    Origio Australasia Pty Ltd

Manufacturer

Origio Australasia Pty Ltd
  • Source
    DHTGA