GET TESTED International AB recalls Gut Microbi:ome Test XL due to distribution without premarket approval. All units are affected. No remedy provided in official recall.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Gut Microbiome Test XL products because they were distributed without proper premarket approval. This means the test may not be safe or effective for use.
The test was distributed without approval from health authorities, which means it may not meet safety or effectiveness standards. This could lead to inaccurate results or health risks if used improperly.
Anyone who purchased the Gut Microbiome Test XL product. The risk is highest for users who rely on the test for medical purposes without proper approval.
Check for the product name 'Gut Microbiome Test XL' and the EAN code 616612785909. All lots of this product are affected.
Look for the EAN code 616612785909 on the product label to confirm it is the recalled item.
The official recall does not provide any remedy or fix for this product.
Check for the EAN code 616612785909 on the product label. All lots of this product are affected.
The recall indicates the product was distributed without premarket approval, so it may not be safe or effective for use.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0782-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0782-2026 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.
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.
