UnratedMedical device recall · FDA · Published January 31, 2022
SD Biosensor STANDARD Q COVID-19 Ag Home Test Not Approved for U.S. Use
SD Biosensor recalls STANDARD Q COVID-19 Ag Home Test kits imported illegally into the U.S. that aren't approved for distribution. These tests may not be safe or effective.
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.
Take action
Contact the company
📍Recalling firmSD Biosensor, Inc.1556 Beon-Gil, Yeongtong, C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero · Suwon, Korea (the Republic of)
“SD Biosensor STANDARD Q COVID-19 Ag Home Test Not Approved for U.S. Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61203-sd-biosensor-standard-q-covid-19-ag-home-test-not. Based on FDA recall #Z-0719-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0719-2022%22&limit=1).
The FDA announced on Jan. 31, 2022, that SD Biosensor, Inc. is recalling approximately 400,000 STANDARD Q COVID-19 Ag Home Test kits due to illegal importation into the U.S., according to GovInfoNow's records.
How to tell if you have it
Brand: SD Biosensor
Product: STANDARD Q COVID-19 Ag Home Test
REF No.: Q-NCOV-03G
Catalog No.: 09COV130
Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
The hazard
The recalled COVID-19 Ag Test kits were illegally imported into the U.S. and are not approved, cleared, or authorized for distribution within the country, according to the FDA.
Context
GovInfoNow's records show SD Biosensor, Inc. has one other recall on record since March 31, 2023: a Pilot COVID-19 At-Home Test recall due to bacterial contamination risk in the liquid buffer component. Other recent recalls of similar products include GET TESTED International AB Recalls GI Microbiome Profile Small Due to Unapproved Distribution (Nov. 3, 2025), GET TESTED International AB: Illegally Marketed Products Recalled (Nov. 3, 2025), and GET TESTED Diabetes Test Kits: Distribution Without Premarket Approval (Nov. 3, 2025).
How to tell if you have this one
Check for the lot number 59628J1T1 (or 59628J1T1/2) on the packaging. These kits were sold through illegal imports and are not approved by the U.S. government.
Brand
SD Biosensor
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 59628J1T1 (or 59628J1T1/2) on the packaging to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0719-2022 (January 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0719-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.