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