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# BASE10 Genetics Kit Recall is Class 1: FDA
- URL: https://www.fdaweb.com/base10-genetics-kit-recall-is-class-1-fda/
- Published: 2022-02-22T12:00:00.000Z
- Updated: 2026-09-14T17:33:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151210

FDA says the 1/20 recall by BASE10 Genetics of its RNAstill MTM specimen collection kits is Class 1\. The company is recalling the kits because they were distributed without proper premarket clearance from FDA. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/base10-genetics-recalls-rnastill-mtm-specimen-collection-kits-are-not-authorized-cleared-or-approved?ref=fdaweb.com) says there are not enough data available about the product to know how well it inactivates and stabilizes a virus for transport and storage.

The company recalled 455,791 units that 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 between 9/16/20 and 12/1/21\. The kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples without dry ice, refrigeration, or special containment.

FDA says if a sample is not properly inactivated and stabilized by the transport medium there are two concerns: 

- if the sample deteriorates, it could lead to false negative results; and
- if the virus isn’t inactivated before testing, it could spread to people in the lab.