GET TESTED International AB recalls Food Intolerance Test Small due to distribution without premarket approval. All units are affected. No remedy provided in official notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Food Intolerance Test Small products because they were distributed without proper regulatory approval. This means the product may not be safe for use as intended.
The product was distributed without premarket approval, meaning it may not meet safety standards. This could lead to inaccurate results or health risks for users.
Anyone who purchased the Food Intolerance Test Small product. People with food allergies or sensitivities who use this test are most at risk.
Check for the product name 'Food Intolerance Test Small' and the EAN code 616612785626. All lots of this product are affected.
Look for the EAN code 616612785626 on the product label to confirm it is the recalled item.
The official notice does not provide a remedy for this recall.
The recalled product is the Food Intolerance Test Small with EAN 616612785626. All lots are affected.
The official notice states the product was distributed without premarket approval, so safety cannot be confirmed.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0808-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0808-2026 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.