Suwon, N/A, Korea (the Republic of)
SD Biosensor, Inc. recalls
2 recalls recorded since 2018, most recently on 31 March 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 31 March 2023
- Reason
- 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.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1594-2023
- Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Ongoing Class I Medical devices
- Recall started
- 31 January 2022
- Reason
- Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
- Distribution
- U.S. Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0719-2022
- STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.