FDA Medical Device Recalls (openFDA)
Haimen Shengbang Laboratory Equipment Co. Ltd.: HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
- Recall number
- Z-1399-2022
- Recalling firm
- Haimen Shengbang Laboratory Equipment Co. Ltd.
- Product
- HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
- Status
- Open, Classified
- Initiated
- 2022-07-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- Distributed VTM outside of VTM Guidance and without clearance.
- Root cause
- No Marketing Application
- Action
- The firm distributed a recall notification via email on 07/12/2022 dated 07/11/2022. This notification identifies the reason for recall to be that all vials of VTM distributed to the United States had not obtained 510K clearance and they weren't approved by FDA under the VTM Enforcement Policy. Customers are asked to identify any unused product and destroy it on-site. Additionally, testing institutions that have used product should evaluate previously obtained test results and evaluate the need to re-test patients. The firm has communicated they intend to apply to FDA for 510K clearance in the future for the recalled device. Customers with any questions are to conact Lei Fan at +86-18938033981 or market@hbxl.net.
- Quantity
- 3,950,000 total units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
- Lot, serial or model codes
- No UDI. All lots distributed in the US.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QMC
- Firm FEI
- 3011676045
- Firm city
- Nantong
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28