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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 IMMULITE/ IMMULITE 1000 Estradiol 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