Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For i…

Recall date

January 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1240-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

Why it was recalled

The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.