GET TESTED International AB recalls Gut Microbi:ome Test Medium due to distribution without premarket approval. No specific action steps listed in the recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all units of their Gut Microbiome Test Medium because it was distributed without proper premarket approval. This recall does not involve a safety hazard that requires immediate action.
The product was distributed without premarket approval, meaning it may not have undergone required safety testing before being sold. However, the recall does not describe any specific safety risks or hazards.
Anyone who purchased the Gut Microbiome Test Medium from retailers. The risk is not specified in the recall notice.
The product is labeled as 'Gut Microbiome Test Medium' with EAN 616612785886 or SKU 2A111. All lots are affected.
Look for the EAN 616612785886 or SKU 2A111 on the product label.
The recall states the product was distributed without premarket approval, but does not describe any specific safety hazards.
The recall does not specify any action steps or safety risks that require stopping use.
The recall does not mention any replacement or remedy options.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0779-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0779-2026 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.
