CLASS I ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report
Hxbl/Wetex/Genesis Biomedical Viral Transport Container recalled
Haimen Shengbang Laboratory Equipment is recalling Hxbl/Wetex/Genesis Biomedical Viral Transport Container, distributed nationwide in the US. The recall was initiated on 12 Jul 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1398-2022
- FDA event ID
- 90602
- Recalling firm
- Haimen Shengbang Laboratory Equipment, Nantong
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jul 2022
- FDA classified
- 8 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Jul 2022 | Recall initiated by company | |
| 8 Aug 2022 | Classified by FDA | +27 days |
| 17 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distributed VTM outside of VTM Guidance and without clearance.
Product as listed by the FDA
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
Questions about this recall
Why was it recalled?
Distributed VTM outside of VTM Guidance and without clearance.
Which lots are affected?
No UDI. All lots distributed in the US.
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 90602| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hxbl/Wetex/Genesis Biomedical Viral Transport Container, Custom Made recalled | Haimen Shengbang Laboratory Equipment | Other | Nationwide | |
| CLASS I | Hxbl/Wetex/Genesis Biomedical Viral Transport Container recalled | Haimen Shengbang Laboratory Equipment | Other | Nationwide |
More recalls from Haimen Shengbang Laboratory Equipment
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Hxbl/Wetex/Genesis Biomedical Viral Transport Container recalled | Haimen Shengbang Laboratory Equipment | Other | Nationwide |
| Device | CLASS I | Hxbl/Wetex/Genesis Biomedical Viral Transport Container, Custom Made recalled | Haimen Shengbang Laboratory Equipment | Other | Nationwide |
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