FDA-Device2017-06-07Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
9100 kits
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2017Don't want to check this manually?
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