Device product
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Z-0504-2022
Product summary
- Firm
- Gentueri Inc
- Event
- Event 89337
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,150 units
- Official record key
device-enforcement:Z-0504-2022
Official wording
Reason: Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
Code information: CAT #: 3300-000; Lot #: 1142
Distribution pattern: US Nationwide distribution in the state of Indiana.
Derived failure modes
-
Unknown
Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.