FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance
The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. The product was distributed without regulatory clearance and in violation of VTM guidance, but no deaths or serious injuries have been reported.
Plain-English summary
The FDA has recalled 3.95 million viral transport containers manufactured by Haimen Shengbang Laboratory Equipment Co. Ltd. The recalled product is the HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1.
The manufacturer distributed these containers without obtaining FDA clearance and outside of established guidance for viral transport media. This violation triggered a Class I recall, the FDA's highest priority classification.
The containers were distributed worldwide, with US distribution in California, Florida, Illinois, and New York. The source does not report any associated illnesses, injuries, or adverse events.
The recalled product
- Product
- HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
- Manufacturer
- Haimen Shengbang Laboratory Equipment Co. Ltd.
- Hazard
- unauthorized-distribution
- regulatory-non-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No UDI. All lots distributed in the US.
Distribution
Distributed nationwide across the United States.
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