Recall Z-1398-2022— Haimen Shengbang Laboratory Equipment Co. Ltd.

Name: FDA recall Z-1398-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-12

Class I · Ongoing

Class I FDA medical device recall by Haimen Shengbang Laboratory Equipment Co. Ltd., initiated 2022-07-12. FDA's recall record names no specific 510(k) clearance for this event. Product: HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type. Reason: Distributed VTM outside of VTM Guidance and without clearance..

Recalling firm: Haimen Shengbang Laboratory Equipment Co. Ltd.
Classification: Class I
Status: Ongoing
Initiated: 2022-07-12
Firm location: Nantong, China

Product description

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

Reason for recall

Distributed VTM outside of VTM Guidance and without clearance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.