Device product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Z-1400-2022
Product summary
- Event
- Event 90602
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 100,000 total units
- Official record key
device-enforcement:Z-1400-2022
Official wording
Reason: Distributed VTM outside of VTM Guidance and without clearance.
Code information: No UDI. All lots distributed in the US.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Derived failure modes
-
Unknown
Distributed VTM outside of VTM Guidance and without clearance.