Events

Safety Alert for ARCHITECT Estradiol Reagent

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Laboratories Ltd.

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
    2016-04-06
  • Event Date Posted
    2016-04-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160406b.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: abbott architect estradiol reagent medical device manufacturer, abbott laboratories ltd, has issued a medical device safety alert concerning its architect estradiol reagent. [list number: 7k72; lot numbers: all]. the manufacturer has 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. in worst case scenarios, falsely elevated estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy. the manufacturer advises users that patients undergoing fulvestrant therapy should not be tested with the architect estradiol assay. 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 6 april 2016.

Device

ARCHITECT Estradiol Reagent
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott ARCHITECT Estradiol Reagent
  • Manufacturer
    Abbott Laboratories Ltd

Manufacturer

Abbott Laboratories Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH