SD Biosensor Pilot Covid-19 Test Kit

SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.

Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.

To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.

The affected test kits were distributed by Roche Diagnostics to distributors and retailers 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.

Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but 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.

This request to discontinue use and dispose of the affected tests is currently isolated to specific lots of the Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, exclusively in the U.S. Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected.

Source: FDA