Qiagen SARS-CoV-2 Antigen Test Recall: False Positive Risk
Qiagen recalls SARS-CoV-2 Antigen Test kits with potential for false positives in some patient samples. Learn about affected lots and how to handle the product.
Lower-risk recall
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Contact the company
What happened, in plain English
Qiagen is recalling certain SARS-CoV-2 Antigen Test kits due to a potential for false positive results in some patient samples. This could lead to incorrect test outcomes, which may affect health decisions. Read more at govinfonow.com/recall/63403-qiagen-sars-cov-2-antigen-test-recall-false-positive-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63403-qiagen-sars-cov-2-antigen-test-recall-false-positive-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0941-2021
Cite this page
“Qiagen SARS-CoV-2 Antigen Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63403-qiagen-sars-cov-2-antigen-test-recall-false-positive-risk. Based on FDA recall #Z-0941-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0941-2021%22&limit=1).
Why it’s dangerous
The test may produce false positive results with certain patient samples, meaning it could incorrectly indicate infection when there is none. This risk is specific to some samples and does not affect all tests equally.
Who’s affected
People who purchased or used the recalled SARS-CoV-2 Antigen Test kits from Qiagen. Those who rely on the test for accurate results are most at risk of incorrect outcomes.
How to tell if you have this one
Check the lot numbers: 86651, 86652, 86653, 86654, or 86659. The product is sold with GTIN 04053228039785 and catalog number 646533.
- Brand
Qiagen- Product
SARS-CoV-2 Antigen Test- Category
Medical device
What to do — step by step
Check Test Lot Number
Look for the lot numbers 86651, 86652, 86653, 86654, or 86659 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed in 18 states and D.C..
FDA distribution: “Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, District of Columbia, Florida, Hawaii, Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Rhode Island, Texas, Washington, Wyoming.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0941-2021 (January 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0941-2021 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.