FDA Enforcement
Class II
Terminated
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.
Recall: Z-0674-2019
·
Reported January 2, 2019
Enforcement
- Recall Number
- Z-0674-2019
- Event ID
- 81597
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 2, 2019
- Initiation Date
- November 30, 2018
- Classification Date
- December 22, 2018
- Termination Date
- January 14, 2021
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895, United States
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.
Code Info
all lots
Distribution
US Nationwide
Quantity
26745 units