FDA Recalls Viral Transport Containers Distributed Without Clearance
FDA recalls approximately 8.7 million viral transport containers that were distributed without regulatory clearance and without complying with FDA guidance for proper viral transport specifications.
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 classified this as a Class I recall, requiring a minimum severity score of 4. No illnesses, injuries, or deaths have been reported in the source material.
Plain-English summary
Haimen Shengbang Laboratory Equipment Co. Ltd. is recalling the HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type, distributed in the United States and internationally. The containers were distributed without FDA clearance and outside the FDA's established guidance for viral transport media.
The FDA classified this as a Class I recall because the product was distributed without the required regulatory authorization and without meeting FDA guidance specifications. Viral transport containers are critical medical devices used to preserve and safely transport viral specimens for testing and diagnostic purposes.
The recalled containers were distributed nationwide in California, Florida, Illinois, and New York, as well as internationally including China. Healthcare facilities, diagnostic laboratories, clinics, and other medical settings that use viral transport containers may have received these products.
Users of these containers should immediately stop using them and contact Haimen Shengbang Laboratory Equipment Co. Ltd. for instructions regarding replacement, return, or proper disposal of the recalled products.
The recalled product
- Product
- HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
- Manufacturer
- Haimen Shengbang Laboratory Equipment Co. Ltd.
- Hazard
- Affected units
- 8,710,600
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 →- SevereViral Transport Container Distributed Without FDA Clearance or Guidance Compliance
FDA (Devices) · 2022-08-17
- SevereFDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance
FDA (Devices) · 2022-08-17
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