Some Pilot COVID-19 at-home test kits may pose safety concerns due to bacterial contamination in the liquid solution that comes in the test kit, FDA warned Thursday afternoon.

Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test, the agency said. The test kits are distributed by Roche Diagnostics and manufactured by SD Biosensor.

SD Biosensor has initiated a recall for all impacted tests that Roche distributed to certain U.S. retailers. About 500,000 tests were distributed to CVS Health, and about 16,000 tests were distributed to Amazon. FDA said it is working with Roche Diagnostics to understand how many of those tests were sold to consumers.

Consumers who received their COVID-19 tests through the COVID.gov/tests distribution or as aprt of other federal testsing programs should be assured that their tests are not part of the recall, according to FDA.
However, if you have a Pilog COVID-19 test with the following lot numbers, you should throw the entire test kit in the trash. Do not pour the liquid solution down the drain, FDA said.

The agency also warns that if the liquid in the tube contacts your skin and eyes, you should flush with large amounts of water. If irritation persists, seek medical attention, FDA said. Anyone exposed to the contaminated liquid solution should also watch for signs of bacterial infection such as fever, discharge, red eyes, or any other concerning symptoms.