On May 4, 2023, the FDA warned consumers and health care providers not to use certain lots of Roche Diagnostics’ SD Biosensor, Inc. Pilot COVID-19 At-Home Tests due to bacterial contamination in the test kit’s liquid solution. Roche has initiated a recall of the affected test kits.

Analysis of the solution found it to be contaminated with Enterococcus, Enterobacter, Klebsiella and Serratia bacteria, which can cause illness in people who come into direct contact with the solution, and in people with weakened immune systems. Bacterial contamination may also affect the performance of the test or cause false test results.

Approximately 516,000 of the recalled tests (see product photos) were distributed to CVS Health and Amazon. None of the recalled tests were distributed through COVID.gov/tests free at-home COVID tests program.

Recalled SD Biosensor Pilot At-Home COVID-19 Tests include the following lot numbers:

• 53K38N1T1
• 53K4221T1
• 53K4292T1
• 53K38N2T1
• 53K4222T1
• 53K42A1T1
• 53K38N3T1
• 53K4223T1
• 53K42A2T1
• 53K38N4T1
• 53K4224T1
• 53K42A3T1
• 53K38N5T1
• 53K4225T1
• 53K42E1T1
• 53K38P1T1
• 53K4231T1
• 53K42G1T1
• 53K38P2T1
• 53K4232T1
• 53K42G2T1
• 53K38P3T1
• 53K4233T1
• 53K42H1T1
• 53K41T5T1
• 53K4261T1
• 53K42H2T1
• 53K41X1T1
• 53K4262T1
• 53K42L1T1
• 53K41X2T
• 53K4271T1
• 53K42L2T1
• 53K42L2T1
• 53K4272T1
• 53K4361AC
• 53K4211T1
• 53K4273T1
• 53K4362AC
• 53K4212T1
• 53K4274T1
• 53K4392AC
• 53K4213T1
• 53K4291T1

Consumers who have the recalled test should throw away the entire kit, and should not pour the liquid solution down the drain. Health care providers should retest any patients who were tested using products with the above lot numbers.

For more information about related products, see the article How can I get tested for the coronavirus? Can I get an at-home test for COVID-19? Which are the best tests? Are any tests free?

For more information, use the link below.

Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication

See related recalls and warnings:

FDA Warns Seller of Unauthorized COVID-19 Tests

FDA Warns Consumers Not to Use LuSys Laboratories COVID Tests Due to False Results

COVID Antibody and Antigen Tests That May Give False Results Recalled

FDA Warns 5 Sellers of Unapproved COVID-19 Tests

FDA Warns Consumers about Fraudulent Tests, Vaccines, and Treatments for COVID-19