GET TESTED International AB recalls Gut Microbi:ome Test Large due to distribution without premarket approval. No specific action steps provided in recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled their Gut Microbiome Test Large product because it was distributed without proper premarket approval. This recall does not include specific instructions for consumers to stop using or return the product.
The product was distributed without premarket approval, meaning it may not have been tested for safety or effectiveness before being sold. This could potentially lead to health risks if the test is not accurate or safe for use.
Anyone who purchased the Gut Microbiome Test Large from retailers. The risk is not specified for individuals using the product.
The Gut Microbiome Test Large with EAN 616612785893 or SKU A130. All lots of this product are affected.
Look for the EAN 616612785893 or SKU A130 on the product label.
The recall notice does not provide specific action steps for consumers.
The recalled product is the Gut Microbiome Test Large with EAN 616612785893 or SKU A130.
The recall states the product was distributed without premarket approval, but does not specify health risks or dangers.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0778-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0778-2026 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.
