FDA recall Z-1743-2022
Aniara Diagnostica LLC · Class III · device
Product
BIOPHEN UFH Control Plasma
Reason for recall
Incorrect product labeling was included in the package.
Distribution
Distribution in US - IL and MI
Key facts
- Status
- Terminated
- Initiation date
- 2022-06-28
- Report date
- 2022-09-21
- Termination date
- 2024-04-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Chester, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2022