Z-1398-2022 Class I Ongoing
FDA device recall Z-1398-2022 was initiated by Haimen Shengbang Laboratory Equipment Co. Ltd. on July 12, 2022 and is designated Class I. Reason for recall: Distributed VTM outside of VTM Guidance and without clearance. The recall status is ongoing. Affected quantity: 8,710,600total units.
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2022
- Initiation Date
- July 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,710,600total units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Code Information
No UDI. All lots distributed in the US.