Events

Retiro De Equipo (Recall) de ACQUITY UPLC Sample Organisers. 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2017-RN-00481-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-20
  • 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-2017-RN-00481-1
  • 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
    The manufacturer, waters corporation has identified an issue with the acquity uplc sample organisers, whereby there is a potential for an internal fuse shield to combust, resulting in a burning odour and instrument failure. an investigation concluded that the potential combustion of the fuse shield would be contained within the instrument with no risk of damage to the samples or the surrounding areas.
  • Acción
    Emergo will send a field engineer to attend the user's facility to modify the affected device (by removing the internal fuse). In the interim, users are advised that if they note a burning odour in or around the instrument, to immediately power down the unit, discontinue use, and call their local representative to report the event.

Device

ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)Model Number: 186015020IVDLot Numbers: G13UPO544M, J13UPO553M, G13UPO542MARTG Number: 201428
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia