The FDA issued a warning to consumers on Thursday to stop using a certain COVID-19 at-home test due to the potential for bacterial contamination in the product’s liquid solution.
In a bulletin, the FDA warned consumers and medical care providers “to stop using and toss out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics.”
The agency said it has “significant concerns of bacterial contamination” in the liquid solution that comes with the kit. “Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,” the FDA said, issuing a “do no use” warning to users.
The FDA said that the product could be contaminated by Enterococcus, Enterobacter, Klebsiella, and Serratia bacterial species. Infection from those types of bacteria could cause illness in individuals with weakened immune systems or those who have direct exposure to the contaminated liquid test solution via misuse, accidental spills, or “standard handling” of the product.
Aside from developing an infection, the contaminated products may also produce “false-negative” or “false-positive” antigen test results, the FDA said, which could lead to a variety of problems. For example, according to the FDA, a false-negative test could result in an individual seeking treatment for COVID-19.
SD Biosensor has initiated the recall for the at-home tests to certain retailers across the United States, according to the FDA announcement.
Some 500,000 tests were distributed through CVS Pharmacy as well as about 16,000 tests that were sent via Amazon. It’s not clear how many were sold to consumers, the FDA said, adding that it is “working with Roche” to determine the number.
Recall Notice – SD Biosensor, Inc. Requests Discontinuation of Use and Disposal of Specific Pilot™ COVID-19 At-Home Tests in the United States Due to Microbial Contamination in the Liquid Buffer Solution https://t.co/xb6GXGrOv8 pic.twitter.com/Ub9evKKHaJ
— U.S. FDA Recalls (@FDArecalls) May 5, 2023
“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,” the agency said. “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.”
