- Medicines and Healthcare products Regulatory Agency
- 24 March 2016
- 24 March 2016
- Alert type:
- Medical device alert
- Medical specialty:
- Critical care
Manufactured by Siemens Healthcare Diagnostics Inc. / Siemens Healthcare Diagnostics Ltd and Roche Diagnostics GmbH- assay interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results. Both Siemens and Roche have issued field safety notices (FSNs) highlighting this issue. Estradiol assays from other manufacturers may also be affected by fulvestrant (Faslodex®) interference and this is currently under investigation (MDA/2016/004).
Action by Laboratory staff
- Determine if estradiol immunoassays are used in your laboratory.
- Continue to use affected estradiol immunoassays for patients not on fulvestrant.
- If measuring estradiol levels in patients on fulvestrant consider alternative methods, such as Liquid Chromatography-Mass Spectrometry (LC-MS).
- Consider the need to carry out a review of previously reported test results.
- Monitor the MHRA website or subscribe to email alerts for any possible further FSNs on this issue.
Action by Healthcare personnel managing patients on this drug
- When test requests include estradiol, state if the patient is on fulvestrant.
- Consider reassessing the menopausal status of patients on fulvestrant by other means where necessary.
Deadlines for actions
Actions underway: 04 April 2016
Actions complete: 25 April 2016
|Assay||Test Code||Catalog Number||Siemens Material Number (SMN)||Lot Number|
|ADVIA Centaur® Enhanced Estradiol1||eE2||10490889 10491445 10697757||10490889 10491445 10697757||All lots|
|Dimension Vista® LOCI Estradiol2||E2||K6463||10489099||All lots|
|IMMULITE®/ IMMULITE 1000 Estradiol||E2||LKE21 LKE21(D)||10381132 10702832||All lots|
|IMMULITE® 2000 Estradiol3||E2||L2KE22 L2KE22 (D) L2KE26 L2KE26 (D)||10381178 10702833 10381177 10702834||All lots|
- The same reagents are used on the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
- The same reagents are used on the Dimension Vista 500 and 1500 systems.
- The same reagents are used on the IMMULITE 2000 and IMMULITE 2000 XPi systems.
|Product Name||Product Description||GMMI / Part No||Lot Number|
|Estradiol II||Elecsys Estradiol II assay||Estradiol II 03000079190||All lots|
|Estradiol III||Elecsys Estradiol III assay||Estradiol III 06656021190||All lots|
Please note oestradiol is used interchangeably with estradiol.
Problem / background
Siemens and Roche both manufacture a number of estradiol assays and have communicated that the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results in assays. Fulvestrant has a similar chemical structure to estradiol and may cross-react with the antibodies used in immunoassays.
Fulvestrant is indicated for the treatment of postmenopausal women with oestrogen receptor positive breast cancer, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen. If the listed estradiol assays are used for this group of post-menopausal women, falsely elevated estradiol results could lead to misinterpretation of the menopausal status of these women. This may result in treatment with fulvestrant being altered.
ADVIA Centaur ®
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591, USA
Tel: Please see below
Email: Please see below
Dimension Vista ®
Siemens Healthcare Diagnostics Inc.
500 GBC Drive
Newark, DE 19714, USA
Tel: Please see below
E Mail: Please see below
Phone contact for the above USA based manufacturers in the UK (European Authorised Representative).
Siemens Healthcare Diagnostics Limited
Newton House, Sir William Siemens Square
Tel: 01908 282 433
IMMULITE ® / IMMULITE 1000, IMMULITE 2000 ®
Siemens Healthcare Products Limited
LLanberis, Caernarfon, Gwynedd, LL55 4EL
Tel: 01286 871 871
Estradiol II/ Estradiol III
Roche Diagnostics GmbH
Sandhofer Strasse 116
Tel: +49 621 759-3511 Email: email@example.com
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Reporting adverse incidents in Wales
Published: 24 March 2016
Issued: 24 March 2016
Alert type: Medical device alert
Medical specialty: Critical care