Recall Z-0674-2019— Tosoh Bioscience Inc

Name: FDA recall Z-0674-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-11-30, terminated 2021-01-14. It names one FDA 510(k) clearance: K023091. Product: 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..

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Terminated: 2021-01-14
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K023091 — ST AIA-PACK TESTOSTERONE ASSAYTosoh Medics, Inc.·cleared 2002-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.