Events

Recall of LIAISON Borrelia 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-2014-RN-01240-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01240-1
  • 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 invalid calibrations due to either a calibrator 1 deviation percentage [%] outside the high limit, or due to the gcc (geometrical curve check) out of range. as a consequence the calibration cannot be validated and the testing with these lots on the analyser cannot be performed.
  • Action
    Diasorin is recommending that use of the affected lot be ceased and any units be discarded. Results obtained with a valid calibration are considered to be reliable; therefore, review of past patient results is not deemed necessary, but at the discretion of the laboratory director. This action has been closed-out on 01/03/2016.

Device

LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).Part number: 310880Lot Number: 089054X , 089054X/1 and 089054X/2Expiry date January 9th, 2016 for all three lots ARTG number: 208811
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd