Events

Safety Alert for Estradiol II and Estradiol III

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diagnostics GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-03-02
  • Event Date Posted
    2016-03-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160302b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche diagnostics estradiol ii and estradiol iii medical device manufacturer, roche diagnostics gmbh, has issued a medical device safety alert concerning its estradiol ii and estradiol iii assays [catalogue number: 03000079190 and 06656021190; lot number: all]. according to the manufacturer, if the estradiol status of postmenopausal women under treatment with fulvestrant is tested with elecsys estradiol ii or elecsys estradiol iii assays, an interference leading to falsely increased results of estradiol due to the drug may occur. subsequently the incorrect level of estradiol may lead to misinterpretations of the hormone status and the use of fulvestrant may be altered. in addition, the efficiency of anti-estrogen treatment might be underestimated. a medical risk for postmenopausal women under fulvestrant treatment cannot be excluded. the manufacturer advises users that due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with fulvestrant. affected users are advised to notify their clinicians that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. if treatment with fulvestrant has been altered or discontinued as a result of falsely elevated estradiol results, an alternate method such as liquid chromatography mass spectrometry (lc-ms), which is not expected to show cross reactivity to fulvestrant, should be used to measure estradiol concentrations and assess the menopausal status of the patient. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2016.

Device

Estradiol II and Estradiol III
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Diagnostics Estradiol II and Estradiol III
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH