Events

Recall of Abbot Architect Estradiol

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    19983
  • Event Initiated Date
    2016-04-08
  • 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: Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, Auckland
  • Reason
    It has been confirmed that the drug fulvestrant (faslodex®) may interfere with the architect estradiol assay (ln 7k72) leading to falsely elevated estradiol results.The potential risk to health applies only to patients being treated with the drug fulvestrant which may lead to increased estradiol results.
  • Action
    Product to be destroyed

Device

Abbot Architect Estradiol

Manufacturer

manufacturer #1479