GET TESTED International AB recalls Gut Microbi:ome Test Small due to distribution without premarket approval. Consumers should contact the company for details.
Distribution without premarket approval/clearance.
GET TESTED International AB is recalling their Gut Microbiome Test Small product because it was distributed without proper regulatory approval. This means the test may not be safe or effective for use.
The product was distributed without premarket approval, meaning it hasn't been tested or approved by regulatory authorities before being sold. This could lead to potential safety or effectiveness issues.
Anyone who purchased the Gut Microbiome Test Small product from retailers. People using the test for health purposes are most at risk.
The product is labeled 'Gut Microbiome Test Small' with EAN 616612785879 or SKU 2A110. All lots of this product are affected.
Reach out to GET TESTED International AB for specific instructions on what to do with the product.
The recall record states the product was distributed without premarket approval, but does not confirm if it is safe to use.
Look for the product label 'Gut Microbiome Test Small' with EAN 616612785879 or SKU 2A110. All lots are affected.
The recall record does not specify a remedy, so contact GET TESTED International AB for instructions.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0781-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0781-2026 from GET TESTED. 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.
