FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits

Editor's Note

The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious.

The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples from patients that need to be tested for COVID-19 and other coronaviruses, influenza, or adenoviruses.

The recall was initiated because the kits were distributed without proper premarket clearance from the FDA, which means there is not enough data available to know how well they inactivate and stabilize viruses for transport and storage.

If samples deteriorate, it could lead to false negative test results. If the virus isn’t inactivated before testing, it could spread to people in the lab. In addition, the transport medium contains a hazardous chemical that requires special training for safe handling.

Distribution dates were September 16, 2020 to December 1, 2021.