medical Class II Updated 2019-01-02

Tosoh Bioscience Inc recalls ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAG

Recalled Product

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.


Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lots
View official government recall

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