Roche, SD Biosensor recall 500,000 at-home COVID tests due to bacteria risks

If you’re still taking home COVID-19 tests, the FDA wants you to double-check the packaging. The agency is warning users of contaminated ingredients in certain packages from SD Biosensor, and distributed by Roche Diagnostics.

The FDA said it has significant concerns about bacteria within the liquid solution provided with the companies’ Pilot at-home kits, including about 500,000 tests shipped to CVS Health pharmacies and 16,000 tests stocked with Amazon.

The agency’s warning to consumers and healthcare providers urged them to stop using and throw out the tests—keeping them sealed, and without pouring the testing liquid down the drain—as direct contact could not only pose safety risks but also potentially affect the accuracy of the results.

The South Korea-based SD Biosensor has launched a recall for the affected Pilot tests, spanning 44 lots, and the FDA said it is working with Roche to determine how many have been sold to customers. 

The agency said that none of the impacted tests were mailed through the U.S. government’s at-home testing program, which has provided screening kits for free through the Postal Service. 

The FDA also said it has not received any reports of injuries or infections to date, and that it is working with SD Biosensor to determine the reason for the contamination and actions to correct it.

The agency previously issued Class I recalls—the FDA’s highest level of risk—for rapid COVID tests based on their rates of false negative and positive results, including last year for LuSys Labs and Celltrion

The FDA has not yet issued a classification for SD Biosensor’s recall. The Roche test took on the Pilot branding last November after it became the company’s first over-the-counter diagnostic to enter the U.S. market.