HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
- Recall Initiated
- July 12, 2022
- Recall Number
- Z-1398-2022
- Quantity
- 8,710,600total units
Reason for Recall
Distributed VTM outside of VTM Guidance and without clearance.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Lot / Code Info
No UDI. All lots distributed in the US.
Root Cause
No Marketing Application
Action Taken
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.