FDA-Device2015-05-27Class II
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
Siemens Healthcare Diagnostics, Inc.
Hazard
IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.
Sold states
Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
Affected count
155 kits
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1629-2015Don't want to check this manually?
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