Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocys…

Recall date
November 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0675-2019
FDA classification
Class II
Brand / firm
Tosoh Bioscience Inc
Sold / distributed
US Nationwide

What was recalled

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.

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