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# FDA Warning on Contaminated Covid Tests
- URL: https://www.fdaweb.com/fda-warning-on-contaminated-covid-tests/
- Published: 2023-05-04T12:00:00.000Z
- Updated: 2026-09-14T18:29:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154378

FDA has issued a warning on SD Biosensor’s Pilot Covid-19 At-Home Tests, distributed by Roche Diagnostics, due to bacterial contamination concerns with its liquid solution. “Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,” the [warning says](https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication?ref=fdaweb.com). SD Biosensor has issued a recall for all affected tests, according to the agency.

FDA says the liquid solution has been found to be contaminated with organisms such as *Enterococcus*, *Enterobacter*, *Klebsiella* and *Serratia* species. “Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube,” it says. Infection from such bacteria may cause illness in people with weakened immune systems, it adds.