FDA recall Z-0504-2022
Gentueri Inc · Class II · device
Product
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Reason for recall
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Distribution
US Nationwide distribution in the state of Indiana.
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-18
- Report date
- 2022-01-26
- Termination date
- 2023-08-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Verona, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2022