Ellume COVID- 19 Home Test Recall: Higher False Positive Risk
Ellume recalls certain COVID-19 home test kits due to higher false positive results. Affected models include I-SRS-C-01 with specific lot numbers. Consumers should check their kit details and contact Ellume for guidance.
Lower-risk recall
Due to a higher rate of false positive test results.
Contact the company
What happened, in plain English
Ellume is recalling specific models of their at-home COVID-19 test kits because they have a higher rate of false positive results. This means the tests might incorrectly show a positive result when the person is actually not infected, which could lead to unnecessary anxiety or actions. Read more at govinfonow.com/recall/61724-ellume-covid-19-home-test-recall-higher-false-positive-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61724-ellume-covid-19-home-test-recall-higher-false-positive-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0183-2022
Cite this page
“Ellume COVID- 19 Home Test Recall: Higher False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61724-ellume-covid-19-home-test-recall-higher-false-positive-risk. Based on FDA recall #Z-0183-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0183-2022%22&limit=1).
Why it’s dangerous
The tests have a higher rate of false positives, meaning they might show a positive result when the person is not infected. This could lead to unnecessary health concerns or actions based on incorrect test results.
Who’s affected
Anyone who owns or uses the recalled Ellume COVID-19 home test kits with the listed catalog numbers and lot numbers. People who have already used these tests may be at risk of false positives.
How to tell if you have this one
Check the catalog number on the test kit, which should be I-SRS-C-01. Look for the specific lot numbers listed in the recall notice, such as 21047-4, 21047-5, and others.
- Brand
Ellume- Category
Medical device
What to do — step by step
Check Your Kit Details
Look for the catalog number I-SRS-C-01 and the specific lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Minnesota, New York, Pennsylvania, Rhode Island, Utah, Washington.
Recall timeline
FDA published this recall 47 days 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-0183-2022 (October 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0183-2022 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.