Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance
Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.
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: This recall is classified as FDA Class I. Per the severity rubric, FDA Class I recalls cannot be scored below 4 (Severe). Although no illnesses or injuries are reported, the unauthorized distribution of a medical device outside of FDA guidance and without FDA clearance constitutes a serious regulatory violation.
Plain-English summary
Haimen Shengbang Laboratory Equipment Co. Ltd. is recalling the HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made. The recall affects approximately 100,000 units distributed worldwide, including United States distribution in California, Florida, Illinois, and New York.
The product was distributed without FDA clearance and outside of FDA guidance for viral transport media. The device was not authorized for distribution in its current form.
Affected organizations should stop use of these containers and contact Haimen Shengbang Laboratory Equipment Co. Ltd. or their supplier regarding the recall.
The recalled product
- Product
- HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
- Manufacturer
- Haimen Shengbang Laboratory Equipment Co. Ltd.
- Affected units
- 100,000
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
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