FDA Provides Update on Base10 Genetics’ Recall of RNA Test Kits
The FDA has issued on update on BASE10 Genetics’ Jan. 10 recall of its RNAstill MTM (molecular transport medium) specimen collection kits, deeming it a Class 1 recall because of the risk of serious injury or death.
The transport medium is designed to deactivate pathogens at the point of collection and stabilize RNA and DNA, allowing safe transport of the specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.
The reason for the recall is that the kits are not authorized, cleared or approved by the FDA, and they require special training for safe handling. If a virus isn’t inactivated prior to testing, it is possible that the virus could spread to people in the lab, the agency said.
The 455,791 affected kits were distributed from Sept. 16, 2020, to Dec. 1, 2021. So far there have been no reports of injuries, adverse health consequences or death associated with the use of the kits, the agency said.