Z-0672-2019 Class II Terminated
FDA device recall Z-0672-2019 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: 19366 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
- 19366 units
Product Description
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Distribution Pattern
US Nationwide
Code Information
all lots