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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00068-1
Product Name/Description ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

ADVIA Centaur Enhanced Estradiol
Catalogue # and SMN: 10490889, 10491445, 10697757

Dimension Vista LOCI Estradiol
Cat # K6463
SMN: 10489099

Cat #: LKE21, LKE21(D)
SMN: 10381132, 10702832

IMMULITE 2000 Estradiol
Cat #: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)
SMN:10381178, 10702833, 10381177, 10702834

All lots affected

ARTG # 175698, 180109 and 179720
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 15/01/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics is conducting a correction for the certain Estradiol products. It has been confirmed that the drug Fulvestrant (Faslodex) may cause falsely elevated Estradiol results in the assays listed, which could lead the clinician to misinterpret the patient as pre-menopausal possibly leading to altered or discontinued use of the potential beneficial drug Fulvestrant.

The risk to health applies to all patients being treated with the drug Fulvestrant.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens’ Estradiol assays may continue to be used to report results for patients not on Fulvestrant therapy; these assays should not be used for patients being treated with Fulvestrant. For patients being treated with Fulvestrant, an alternate method such as LC-MS which is not expected to show cross reactivity to Fulvestrant should be used to measure Estradiol concentrations.

This action has been closed out on 26/09/2018
Contact Information 1800 310 300 - Siemens Technical Support Centre