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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00391-1
Product Name/Description	ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD) List Number: 7K72 All lot numbers affected ARTG Number: 180112
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/04/2016
Responsible Entity	Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue	Abbott has identified that the drug Fulvestrant (Faslodex) may interfere with the ARCHITECT Estradiol assay (LN 7K72) leading to falsely elevated Estradiol results. In worst case scenarios, falsely elevated Estradiol results may lead to incorrect menopausal state assessment and inappropriate therapy.
Recall Action	Recall for Product Correction
Recall Action Instructions	Abbott is advising users that patients undergoing Fulvestrant therapy should not be tested with the Architect Estradiol assay. Users are advised to review this letter with the laboratory Medical Director. This action has been closed-out on 20/02/2017.
Contact Information	1800 816 696 - Abbott Customer Support