FDA Device recall Z-1398-2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
- FDA Device
- Class I
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class I recall of HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type by Haimen Shengbang Laboratory Equipment, citing distributed VTM outside of VTM Guidance and without clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1398-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-07-12 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Haimen Shengbang Laboratory Equipment |
| Distribution | US |
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Reason
Distributed VTM outside of VTM Guidance and without clearance.
Identifiers
| code_info | No UDI. All lots distributed in the US. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1398-2022%22
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