Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Brand
Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China
Lot Codes / Batch Numbers
No UDI. All lots distributed in the US.
Products Sold
No UDI. All lots distributed in the US.
Haimen Shengbang Laboratory Equipment Co. Ltd. D, Sanhe No. 50 Xue Qian Road; Sanhezhen Haimen Nantong China is recalling HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type due to Distributed VTM outside of VTM Guidance and without clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distributed VTM outside of VTM Guidance and without clearance.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026