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.
Due to distributing test kits to customers who were not part of a clinical investigation.
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.
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.
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.
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.
Look for lot numbers U2102003 or X2012310 on the packaging of the Innova 3T COVID-19 self-test kits.
The recall is because the test kits were distributed to customers who were not part of a clinical investigation.
Lot numbers U2102003 and X2012310 are affected.
Check the packaging for lot numbers U2102003 or X2012310 and catalog number 3T.
We’ve drafted a message you can send Innova to request your refund or repair — edit it as you like.
Subject: Recall Z-1539-2021 — Innova Innova Hello, I own a Innova that is covered by recall Z-1539-2021 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.
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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.
