Events

Recall of Siemens IMMULITE/ IMMULITE 1000 Estradiol

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens Healthcare Diagnostics Inc.

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
    19675
  • Event Initiated Date
    2016-01-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    Manufacturer has confirmed the drug fulvestrant (faslodec) may cause elevated estradiol results in the assays listed. fulvestrant is used in post-menopausal women treated for oestrogen receptor positive recurent stage 1v breast cancer.If the listed estradiol assays are used to assess the menopausal status of such a patient population, falsely elevated estradiol levels could lead the clinician to misinterpret the patient as premenopausal possbly leading to altered or discontinued use of the potential beneficial drug fulvestrant.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens IMMULITE/ IMMULITE 1000 Estradiol

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA