SD Biosensor recalls

SD Biosensor has 2 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 31 May 2023. 2 are still ongoing. The most frequent reason is device malfunction.

Total recalls2since 2022

Last 12 months0reported

Class I2100% of total

Ongoing2latest 31 May 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 100%Class II 0 0%Class III 0 0%

Why sd biosensor is recalled

Device Malfunction150%
Hidden Drug Ingredients150%

Product types

Test Kits & Diagnostics2100%

By year

2023150%
2022150%

Ongoing sd biosensor recalls

2 active

Reported	Class	Recall	Company	Reason	Where
31 May 2023Device	CLASS I	Pilot Covid-19 At-Home Test, Reference Number 9901-Ncov recalled	SD Biosensor	Device Malfunction	Nationwide
23 Mar 2022Device	CLASS I	Standard Q Covid-19 Ag Home Test Standard Q Covid-19 Ag recalled	SD Biosensor	Hidden Drug Ingredients	Nationwide

All sd biosensor recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
31 May 2023Device	CLASS I	Pilot Covid-19 At-Home Test, Reference Number 9901-Ncov recalled	SD Biosensor	Device Malfunction	Nationwide
23 Mar 2022Device	CLASS I	Standard Q Covid-19 Ag Home Test Standard Q Covid-19 Ag recalled	SD Biosensor	Hidden Drug Ingredients	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.