Events

Recall of Liaison Control Mumps IgG (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 DiaSorin Australia Pty Ltd.

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-2013-RN-00697-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00697-1
  • 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
    Diasorin has confirmed an increased rate of invalid runs with the identified control lots.
  • Action
    DiaSorin is requesting users to identify and discard all affected lots. Replacement product will be provided free of charge.

Device

Liaison Control Mumps IgG (an in vitro diagnostic medical device (IVD))
  • Model / Serial
    Liaison Control Mumps IgG (an in vitro diagnostic medical device (IVD))Catalogue number: 318841Batch Number: 164007X and 164007X/1Expiry Date: 08 December, 2013ARTG number: 193604
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd