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.
Due to a higher rate of false positive test results.
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.
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.
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.
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.
Look for the catalog number I-SRS-C-01 and the specific lot numbers listed in the recall notice.
Ellume is recalling these tests because they have a higher rate of false positive results.
Check the catalog number on the test kit, which should be I-SRS-C-01, and look for the specific lot numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Ellume directly for guidance.
We’ve drafted a message you can send Ellume to request your refund or repair — edit it as you like.
Subject: Recall Z-0183-2022 — Ellume Ellume Hello, I own a Ellume that is covered by recall Z-0183-2022 from Ellume. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.