Payam Javan: The Food and Drug Administration (FDA) has issued a warning regarding a specific brand of at-home COVID-19 test that may lead to bacterial infection. Roche Diagnostics is recalling its SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, as indicated by the FDA’s announcement. The affected tests are associated with 44 specific lot numbers. CVS Health received approximately 500,000 tests, while the remaining 16,000 were distributed to Amazon. The exact number of units sold is unknown at this time.
Consumers who have purchased kits with the affected lot numbers are advised by the FDA to discard the entire kit. The FDA cautions against inhaling the liquid solution in the kit and recommends washing the skin or eyes if they come into contact with the liquid. The affected batches contain bacteria from species such as Enterococcus, Enterobacter, Klebsiella, and Serratia.
In addition to the bacterial infection risk, the FDA has also warned about the potential for false positive and false negative results with these at-home tests. False positive results may indicate COVID-19 infection when the individual is not actually infected, while false negatives may occur when the test fails to detect the presence of the virus. As a precautionary measure, the FDA suggests that patients who have undergone testing within the past two weeks should consider getting retested.