FDA recall Z-0561-2022
Gentueri Inc · Class II · device
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Reason for recall
Kits failed sterility testing and showed evidence of contamination.
Distribution
Domestic: Illinois, Nebraska, and Wisconsin.
Key facts
- Status
- Terminated
- Initiation date
- 2020-07-06
- Report date
- 2022-02-16
- Termination date
- 2023-12-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Verona, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2022