The Recall Desk
SevereFDA (Devices)·Z-1398-2022·Announced 2022-08-17

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.

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 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.
Category
Medical Device — Viral Transport Containers
Hazard
  • improper-containment

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.

Related recalls

Same category