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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 017 04 16 000
Date submitted: 4/5/2016
Manufacturer:Abbott
Device Type:ARCHITECT Estradiol Reagent
Description:IVD, Reagent
Medical Device Identifier:list number (LN) 7K72 All lot numbers
Reason of Field Safety Corrective Action:Abbott has confirmed that the drug Fulvestrant (Faslodex®) may interfere with the ARCHITECT Estradiol assay (LN 7K72) leading to falsely elevated Estradiol results.
Remedy Action:- Please review this letter with your Medical Director.

- Patients undergoing Fulvestrant therapy should not be tested with the ARCHITECT Estradiol assay.

- Complete the Customer Reply Form.

- If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.

- Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:F73072E4812FE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf