Recall Z-1399-2022— Haimen Shengbang Laboratory Equipment Co. Ltd.
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-K59-1. 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-K59-1
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.