Events

Recall of Liaison Biotrin Control 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-2013-RN-01345-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01345-1
  • 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
    Internal investigation confirmed that the certificates of analysis of the liaison biotrin control parvovirus b19 igm (p/n 317011), lot numbers 130010x, 130010x/1, 130012x, 130012x/1 & 130012x/2, are reporting an incorrect negative control range for the liaison xl application, when used in combination with liaison biotrin parvovirus b19 igm (317010) kit lots numbers 129019x & 129019x/1. the negative control range for these lots of liaison biotrin control parvovirus b19 igm should be 0.0 - 0.5 index instead of 0.0 - 0.3 index as previously reported in the incorrect certificate of analysis.
  • Action
    DiaSorin has notified their customers of the change to the range of the Liaison Control for Biotrin Parvovirus B19 IgM.

Device

Liaison Biotrin Control Parvovirus B19 IgM
  • Model / Serial
    Liaison Biotrin Control Parvovirus B19 IgMPart Number: 317011Lot Numbers: 130010X, 130010X/1, 130012X, 130012X/1 & 130012X/2
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd