Z-0674-2019 Class II Terminated
FDA device recall Z-0674-2019 was initiated by Tosoh Bioscience Inc on November 30, 2018 and is designated Class II. The recall status is terminated (terminated January 14, 2021). Affected quantity: 26745 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- November 30, 2018
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26745 units
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.
Distribution Pattern
US Nationwide
Code Information
all lots