SD Biosensors has initiated a recall of certain Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics in the U.S.

The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older and by an adult for children ages 2 to 13 years old.

The recall process follows the U.S. Food and Drug Administration (FDA) warning consumers and healthcare providers to stop using certain lot numbers of SD Biosensor’s Pilot COVID-19 At-Home Tests sold in the U.S. due to contamination last Thursday.

According to the FDA, the action is due to bacterial contamination of the reagents in the Pilot COVID-19 At-Home Tests, and the FDA has released the lot numbers of the 44 affected products.

“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,” the FDA said. “Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube.”

Such contact may result in misdiagnoses and illness in immunocompromised individuals, the FDA added.

The FDA said until now, no adverse events have been reported after using the self-test kits.

SD Biosensor added that the affected tests could be identified by the lot number on the outer packaging and should be appropriately discarded.

The company warned users to dispose of the entire test kit in the household trash and not to pour the liquid down the drain.

SD Biosensor was unavailable for immediate comments regarding the issue.