Events

Recall of LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). 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-2016-RN-00942-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00942-1
  • 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 is issuing a correction for the liaison estradiol ii gen assay. due to the risk of recently identified cross-reactivity, the liaison estradiol ii gen assay should not be used to test patients being treated with fulvestrant (faslodex). cross reactivity of the drug fulvestrant may lead to falsely elevated test results in estradiol assays. this is due to the fact that fulvestrant has a similar chemical structure to estradiol and may cross-react with antibodies used in immunoassays. fulvestrant is indicated for the treatment of post-menopausal women with estrogen receptor positive recurrent stage iv breast cancer.
  • Action
    DiaSorin is advising users to use an alternative method if measuring estradiol levels in patients being treated with fulvestrant, and advise clinicians that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. It is recommended laboratories consider the need to carry out a review of previously generated results. DiaSorin will be updating the Instructions for Use (IFU) to contain additional warnings. This action has been closed-out on 22/02/2017.

Device

LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vi...
  • Model / Serial
    LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)Part Number: 310680All Lots affectedARTG Number: 201366
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd