FDA recall Z-1399-2022

Haimen Shengbang Laboratory Equipment Co. Ltd. · Class I · device

Product

HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

Reason for recall

Distributed VTM outside of VTM Guidance and without clearance.

Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.

Key facts

Status
Ongoing
Initiation date
2022-07-12
Report date
2022-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nantong, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2022