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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