Base10 Genetics is recalling the RNAstill MTM specimen collection kits because they were distributed without proper premarket clearance from the FDA—meaning there is not adequate data available about this product to know how well it inactivates and stabilizes a virus for transport and storage, according to an agency alert.
Base10 Genetics RNAstill MTM specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal (deep inside the nose to the back of the throat) or oropharyngeal (just beyond the mouth into the throat) swab samples from patients, without needing dry ice, refrigeration, or special containment.
They can be used to collect and store patient samples that need to be tested for viruses including SARS-CoV-2 (the virus that causes COVID-19) and other coronaviruses, influenza (flu), or adenoviruses (viruses that typically cause the common cold). They can also be used for patient samples that need to be tested for bacteria that commonly cause infections including Mycoplasma pneumoniae, Chlamydia pneumoniae, Streptococcus pneumoniae, and Streptococcus pyogenes.
If the specimen collected is not properly inactivated and stabilized by the transport medium, there are two concerns:
- If the sample deteriorates, it could lead to false negative test results
- If the virus isn’t inactivated prior to testing, it is possible that the virus could spread to people in the lab.
These products were distributed to nursing homes, assisted living facilities, and memory facilities whose residents are at high risk of severe illness and death from COVID-19. A false negative test result could lead to a patient not receiving the care they need.
Additionally, the transport medium of this specimen collection kit contains a hazardous chemical that requires special training for safe handling. It is not certain that staff at long term care facilities where the product was distributed are trained to safely handle this hazardous chemical.
As a result of all these issues, use of the affected product could cause serious adverse health consequences and death.
There have been no reports of injuries, adverse health consequences or death associated with the use of this product.
More information is available on the FDA website.