GET TESTED International AB recalls Akkermansia Test due to distribution without premarket approval. All units are affected. No specific action steps provided in recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Akkermansia Test products because they were distributed without proper premarket approval. This means the product may not meet safety standards before being sold.
The product was distributed without premarket approval, meaning it may not have undergone required safety testing before being sold. This could lead to potential health risks if the product is used without proper regulatory oversight.
Anyone who purchased the Akkermansia Test product from any source. The risk is highest for individuals using the product for medical testing without proper regulatory oversight.
The product is labeled as 'Akkermansia Test' with EAN 616612787187 and SKU 2A171. All lots of this product are affected.
Look for the product name, EAN 616612787187, and SKU 2A171 on the item.
The product was distributed without premarket approval, meaning it may not have undergone required safety testing before being sold.
The recall notice does not provide specific action steps for consumers.
The product is labeled as 'Akkermansia Test' with EAN 616612787187 and SKU 2A171. All lots are affected.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0773-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0773-2026 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.
