Innova recalls 7T COVID-19 self-test kits distributed outside clinical trials. These kits may be used by non-clinical participants, posing unintended health risks. Consumers should check lot numbers for affected units.
Due to distributing test kits to customers who were not part of a clinical investigation.
Innova is recalling its 7T COVID-19 self-test kits because they were distributed to customers outside of clinical trials. This could mean the kits are being used by people who aren't part of a controlled study, potentially leading to inaccurate results or unintended health risks.
The kits were distributed to customers who weren't part of a clinical investigation. This means the tests might not be validated for general use, potentially leading to inaccurate results. Using them outside of controlled studies could cause incorrect health assessments.
Anyone who purchased the Innova 7T COVID-19 self-test kit with lot numbers U2101748, U2102001, U2102002, X2012711, or X2103792. People using these kits outside of clinical trials may be at higher risk of inaccurate results.
Check the lot numbers on the kit: U2101748, U2102001, U2102002, X2012711, or X2103792. The product name is 'Innova 7T COVID-19 Self-Test Kit'.
Look for lot numbers U2101748, U2102001, U2102002, X2012711, or X2103792 on the kit packaging.
The kits were distributed to customers who were not part of a clinical investigation, meaning they may not be validated for general use.
Check the lot numbers on the kit packaging. If it matches the recalled numbers, you may want to contact Innova for guidance.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Innova to request your refund or repair — edit it as you like.
Subject: Recall Z-1537-2021 — Innova Innova Hello, I own a Innova that is covered by recall Z-1537-2021 from Innova. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
