SD Biosensor, Inc. recalls Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-

Recalled May 31, 2023 · FDA recall Z-1594-2023 · SD Biosensor

Hazard

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose. · FDA Class I

Units

2,712,767 kits

Sold at

US Nationwide.

Description

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

Product

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

Manufacturer(s)

SD Biosensor, Inc.

Made in

Korea (the Republic of)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →