Yahoo Finance Product recall: FDA warns of bacterial contamination in certain Pilot COVID-19 tests
Consumers and health care providers should throw out certain lots of recalled COVID-19 at-home tests over "significant concerns" of bacterial contamination that may lead to infection, according to the U.S. Food and Drug Administration.
The recall includes certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics found to be contaminated with organisms such as enterococcus, enterobacter, klebsiella, and serratia species. Direct contact with the contaminated liquid inside the kits' prefilled tubes could lead to false results and cause illness, especially among those with weakened immune systems.
The FDA says it has not received reports of injuries, adverse health consequences, or death associated with the testing kit.
The FDA and Roche Diagnostics are unsure how many test kits were sold to consumers. About 500,000 tests were distributed to CVS Health and another 16,000 to Amazon. None of the impacted lots were distributed through federal testing programs.
There are 44 affected lot numbers that should be thrown out, which can be found on the FDA’s website.
Consumers who are in possession of a recalled testing kit should throw the entire kit in their trash. The FDA says the liquid solution should not be poured down the drain.
According to the FDA, those who used the testing kit should seek medical attention if there are signs of infection like fever, discharge, or red eyes. Skin or eyes that made contact with the liquid in the tube should be flushed with water.
The FDA’s statement on Thursday says the agency is working with SD Biosensor to resolve the situation, determine its origins and assess corrective actions. SD Biosensor in a press release noted the product has not yet been FDA cleared or approved but was authorized by the FDA under an Emergency Use Authorization.
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This article originally appeared on USA TODAY: Food and Drug Administration recalls some Pilot COVID-19 at-home tests
