Events

Recall of LIAISON Biotrin Parvovirus B19 IgM

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-2014-RN-00879-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00879-1
  • 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 become aware that the kit lots identified have a potential to produce an increased rate of positive results when used on liaison xl analyzer.
  • Action
    DiaSorin is recommending the retesting of all specimens resulting in an initial positive on the LIAISON XL analyzer unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. The affected lots can still be used, but confirming all initially positive results with a different method or analyzer. DiaSorin is offering Parvovirus B19 IgM EIA, code V619IM free of charge to perform the retesting. This action has been closed-out on 03/06/2016.

Device

LIAISON Biotrin Parvovirus B19 IgM
  • Model / Serial
    LIAISON Biotrin Parvovirus B19 IgMPart Number: 317010Lot Number: 129022X, 129022X/1Expiry Date: 12 December, 2014ARTG Number: 203754An in vitro diagnostic medical device (IVD)
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd