FDA-Device2019-01-02Class II
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Sold states
US Nationwide
Affected count
992 units
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2019More Tosoh Bioscience Inc recalls
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