Events

Recall of Elecsys Estradiol Assay with Fulvestrant. 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 Roche Diagnostics Australia Pty Limited.

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-00482-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00482-1
  • 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
    Roche diagnostics has tested for fulvestrant interference / cross-reactivity with the elecsys estradiol assay; this investigation has shown that fulvestrant could potentially affect patient sample results. the reported issue may lead to falsely elevated results of estradiol. subsequently, misinterpretation of the hormone status could occur and the use of fulvestrant may be altered. in addition, the efficiency of anti-estrogen treatment might be underestimated.
  • Action
    Roche is advising customers that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. A review of estradiol assay results in patients taking fulvestrant is recommended. A disclaimer will be added to the “Interference – Limitations” section in the Method Sheet of the Elecsys Estradiol III assay: This action has been closed-out on 30/01/2017. “Due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with Fulvestrant.”

Device

Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited