SD Biosensor, Inc. FDA Recalls

2 recalls on file across devices, 2 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-Class IMar 31, 2023The liquid buffer component in the affected test kit lots wa	The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. Use	Class IDevices	Mar 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualClass IJan 31, 2022Illegal importation of COVID-19 AG Test kits into the U.S. T	Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or a	Class IDevices	Jan 31, 2022