GET TESTED International AB recalls GI Microbiome Profile XL (EAN 734:221709225) due to distribution without premarket approval. Consumers should check product details to determine if affected.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all GI Microbiome Profile XL products because they were distributed without proper regulatory approval. This recall does not pose a direct safety risk to users but requires consumers to check if they have the affected product.
The product was distributed without premarket approval or clearance from regulatory authorities. This means it may not meet safety standards, but the recall does not indicate an immediate risk of injury or harm to users.
Anyone who purchased the GI Microbiome Profile XL product from any retailer. Consumers with the product are most at risk if they do not check the recall status.
Check for the EAN code 7340221709225 or SKU UGXL on the product label. All lots of this product are affected by the recall.
Look for the EAN 7340221709225 or SKU UGXL on the product label to confirm if it is affected.
The recall indicates the product was distributed without premarket approval, but it does not state that the product is unsafe for use. Consumers should check if they have the affected product.
The recall does not require stopping use; it only asks consumers to check if they have the affected product.
Check the product label for the EAN 7340221709225 or SKU UGXL to confirm if it is affected. If affected, you do not need to take further action beyond checking.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0764-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0764-2026 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.
