FDA-Device2022-08-17Class I

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

Haimen Shengbang Laboratory Equipment Co. Ltd.
Hazard

Distributed VTM outside of VTM Guidance and without clearance.

Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Affected count
3,950,000 total units
Manufactured in
D, Sanhe, No. 50 Xue Qian Road; Sanhezhen Haimen, Nantong, China
Products
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

Official notice

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

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