The FDA issued a warning last week to stop using a particular COVID at-home test due to the potential for bacterial contamination in the product’s solution.
In the warning, the FDA told 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 included in 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 continued.
Apart from developing an infection, the products may also produce “false-negative” or “false-positive” antigen test results, the agency revealed.
From NTD News:
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. SD Biosensor has initiated the recall for the at-home tests to certain retailers across the United States, according to the FDA announcement.
