Events

Recall of ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00481-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00481-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)
  • Model / 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