![]() In addition to the risk of infection, this contamination may impact the performance of the test, and false results may occur. 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. 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. Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. 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. Report any problems you experience with the Pilot COVID-19 At-Home Test to the FDA, including suspected false results.If they have, consider whether their infection may be from exposure to the contaminated buffer solution. If a patient presents with signs of bacterial infection, such as fever, conjunctivitis, or other signs or symptoms of systemic infection, consider whether they have recently used a Pilot COVID-19 At-Home Test.If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest. If an antigen test was performed less than two weeks ago using the Pilot COVID-19 At-Home Test, consider retesting your patients using an FDA authorized or cleared SARS-CoV-2 diagnostic test if you suspect an inaccurate result.Recommendations for Health Care Providers and Testing Program Organizers Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results. ![]() If you see signs of infection, such as fever, discharge, red eyes, or any other concerning symptoms, seek medical attention. Watch for signs of bacterial infection caused by exposure to the contaminated liquid solution.If irritation persists, seek medical attention. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water.Additional information can be found in the Quick Reference Instructions for patients. Do not pour the liquid solution down the drain. ![]() Throw out the entire test kit in the household trash.
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