FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers
The FDA issued an update on Haimen Shengbang Laboratory’s July 12 recall of its Viral Transport Media Containers, deeming it a Class 1 recall because of the risk of serious injury or death.
The containers are used to transport specimen samples to a laboratory for testing, including testing for viruses such as SARS-CoV-2, the virus that causes COVID-19.
The items were distributed without authorization, clearance or approval, the agency said. The 4,165,200 affected products were distributed from Oct. 8, 2021 to Feb. 15.
The agency said that the products were distributed without authorization, clearance or approval and that they pose a risk of false results, that could lead to serious adverse health consequences or death.
There have been no complaints or reports of injuries or deaths associated with the use of this product so far, the FDA said.