Innova 3T COVID-19 Self-Test Kit Recall: Incorrect Distribution Risk
Innova recalls 3T COVID-19 self-test kits distributed outside clinical trials. This may pose risks if used by non-clinical participants. Affected kits have specific lot numbers.
Recall notice
Due to distributing test kits to customers who were not part of a clinical investigation.
Contact the company
What happened, in plain English
Innova is recalling its 3T COVID-19 self-test kits because they were distributed to customers outside of clinical trials. This could mean the kits aren:1t properly validated for general use, potentially leading to inaccurate results. Read more at govinfonow.com/recall/62802-innova-3t-covid-19-self-test-kit-recall-incorrect-distribution.
Source Summary by GovInfoNow · govinfonow.com/recall/62802-innova-3t-covid-19-self-test-kit-recall-incorrect-distribution · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1539-2021
Cite this page
“Innova 3T COVID-19 Self-Test Kit Recall: Incorrect Distribution Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62802-innova-3t-covid-19-self-test-kit-recall-incorrect-distribution. Based on FDA recall #Z-1539-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1539-2021%22&limit=1).
Why it’s dangerous
The kits were distributed to customers who weren't part of a clinical investigation. This means the test kits might not have been properly validated for general use, potentially leading to inaccurate results. The hazard is related to the distribution process rather than the test kit itself.
Who’s affected
People who purchased the Innova 3T COVID-19 self-test kits with lot numbers U2102003 or X2012310 are affected. Those using these kits outside clinical trials may be at higher risk of inaccurate results.
How to tell if you have this one
Check for the lot numbers U2102003 or X2012310 on the packaging of the Innova 3T COVID-19 self-test kits. The product is identified by the catalog number 3T.
- Brand
Innova- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1537-2021 | COVID-19 Self-Test Kit *** INNOVA *** 7T; Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792 | 370 boxes (=2,590 individual tests) |
| Z-1538-2021 | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309; Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038 | 1,945 boxes (=48,625 individual tests) |
| Z-1539-2021 | COVID-19 Self-Test Kit *** INNOVA *** 3T; Catalog Number: 3T Lot Numbers: U2102003 X2012310 | 402 boxes (=1,206 tests) |
What to do — step by step
Check Product Lot Numbers
Look for lot numbers U2102003 or X2012310 on the packaging of the Innova 3T COVID-19 self-test kits.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 33 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1539-2021 (April 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1539-2021 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.