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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 3,950,000
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
Part of a larger recall action
This product is one of 3 recalled by Haimen Shengbang Laboratory Equipment Co. Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Haimen Shengbang Laboratory Equipment Co. Ltd.
See all →- SevereFDA Recalls Viral Transport Containers Distributed Without Clearance
FDA (Devices) · 2022-08-17
- SevereViral Transport Container Distributed Without FDA Clearance or Guidance Compliance
FDA (Devices) · 2022-08-17
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