FDA Enforcement
Class II
Terminated
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.
Recall: Z-0672-2019
·
Reported January 2, 2019
Enforcement
- Recall Number
- Z-0672-2019
- 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
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.
Code Info
all lots
Distribution
US Nationwide
Quantity
19366 units