Events

Rappel de ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00481-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00481-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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