STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is… — Class I medical device recall Z-0719-2022
Ongoing recall by SD Biosensor, Inc., reported 2022-03-23, distributed nationwide. Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or a
| Recall number | Z-0719-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SD Biosensor, Inc., Suwon, N/A, Korea (the Republic of) |
| Recall initiated | 2022-01-31 |
| Classified | 2022-03-15 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 400,000 kits |
| Reason classes | unapproved product |
| Lot numbers | 59628J1T1 |
| Model numbers | 09COV130, Q-NCOV-03G |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0719-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.