FDA-Device2019-01-02Class II
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.
Sold states
US Nationwide
Affected count
26745 units
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0674-2019More Tosoh Bioscience Inc recalls
- FDA-Device2026-07-22Tosoh Bioscience ST AIA-Pack Testosterone test recalled for inaccurate results
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