Seoul, South Korea -based SD Biosensor, Inc. has recalled specific Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics in the United States, citing potential microbial contamination in the liquid buffer solution, the U.S. Food and Drug Administration said.
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 product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization. The authorization is only for the detection of proteins from SARS-CoV-2, and not for any other viruses or pathogens.
The agency asked consumers to stop using and dispose of the affected pilot tests as potentially harmful bacteria were found in the tube with liquid inside, in pouch 2 of the kits.
The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube. A user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.
Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.
However, no such illness has been reported related to the recalled product to date.
The affected tests come with lot numbers 53K38N1T1, 53K38N2T1, 53K38N3T1, 53K38N4T1, 53K38N5T1, 53K38P1T1, 53K38P2T1, 53K38P3T1, 53K41T5T1, 53K41X1T1, 53K41X2T1, 53K41X3T1, 53K4211T1, 53K4212T1, 53K4213T1, 53K4221T1, 53K4222T1, 53K4223T1, 53K4224T1, 53K4225T1, 53K4231T1, 53K4232T1, 53K4233T1, 53K4261T1, 53K4262T1, 53K4271T1, 53K4272T1, 53K4273T1, 53K4274T1, 53K4291T1, 53K4292T1, 53K42A1T1, 53K42A2T1, 53K42A3T1, 53K42E1T1, 53K42G1T1, 53K42G2T1, 53K42H1T1, 53K42H2T1, 53K42L1T1, 53K42L2T1, 53K4361AC, 53K4362AC, 53K4392AC.
They were distributed by Roche Diagnostics to distributors and retailers in the U.S.
Meanwhile, Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected by the recall. The consumers are asked to dispose of the entire recalled test kit in the household trash, and not to pour the liquid down the drain.
If the liquid in the tube contacts one's skin and eyes, they are asked to flush with large amounts of water and if irritation persists, seek medical attention.
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