Do Not Use Certain SD Biosensor Pilot COVID

Oct 14, 2023

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Date Issued: May 4, 2023

The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.

SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.

Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs. If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall.

The FDA is advising consumers to stop using and throw out Pilot COVID-19 At-Home Test kits with the following lot numbers:

The liquid solution provided in the affected Pilot COVID-19 At-Home Test kits 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. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with contaminated liquid buffer during opening the tube or handling of the open tube or while performing the test.

Infection from bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species may cause illness in people with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product.

In addition to the risk of infection, this contamination may impact the performance of the test, and false results may occur.

The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the SD Biosensor Pilot COVID-19 At-Home Test to date.

The SD Biosensor Pilot COVID-19 At-Home Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen found in the SARS-CoV-2 virus. This test is authorized for non-prescription home use, self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older.

The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk. The FDA is continuing to work with SD Biosensor Inc. to assess the company's corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.

The FDA will continue to keep the public informed of significant new information.

If you think you had a problem with the SD Biosensor Pilot COVID-19 At-Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Generally, as specified in a test's Emergency Use Authorization, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations.

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

05/04/2023