Medical device recalls High risk

Haimen Shengbang Laboratory Equipment Co. Ltd. recalls HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

Recall date
July 12, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1398-2022
FDA classification
Class I
Brand / firm
Haimen Shengbang Laboratory Equipment Co. Ltd.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.

Why it was recalled

Distributed VTM outside of VTM Guidance and without clearance.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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