Siemens Healthcare Diagnostics, Inc. recalls SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the q…

Recall date

January 31, 2017

Source

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

Recall number

Z-2166-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿C, as published in the Instructions for Use (IFU). Adjustors stored at 2-8C after 14 days may show a bias in patient samples and quality control falling outside of published ranges. Lookback not recommended.

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

What was recalled

SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.