Device product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Z-0561-2022
Product summary
- Firm
- Gentueri Inc
- Event
- Event 89336
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,975 units (2 mL in a 15 mL conical tube)
- Official record key
device-enforcement:Z-0561-2022
Official wording
Reason: Kits failed sterility testing and showed evidence of contamination.
Code information: CAT#: 3300-000; Lot No.: 1029.
Distribution pattern: Domestic: Illinois, Nebraska, and Wisconsin.
Derived failure modes
-
Unknown
Kits failed sterility testing and showed evidence of contamination.