Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurem…

Recall date
November 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0673-2019
FDA classification
Class II
Brand / firm
Tosoh Bioscience Inc
Sold / distributed
US Nationwide

What was recalled

ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.

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