FDA Enforcement
Class II
Terminated
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.
Recall: Z-0675-2019
·
Reported January 2, 2019
Enforcement
- Recall Number
- Z-0675-2019
- 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 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.
Code Info
all lots
Distribution
US Nationwide
Quantity
992 units