Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testost…

Recall date
November 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0674-2019
FDA classification
Class II
Brand / firm
Tosoh Bioscience Inc
Sold / distributed
US Nationwide

What was recalled

ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

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