Z-0675-2019 Class II Terminated
FDA device recall Z-0675-2019 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: 992 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
- 992 units
Product Description
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Distribution Pattern
US Nationwide
Code Information
all lots