GET TESTED INTERNATIONAL AB recalls Sorbitol Intolerance Test due to distribution without premarket approval. All units are affected. No remedy provided.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling all units of their Sorbitol Intolerance Test product because it was distributed without proper regulatory approval. This means the test may not be safe or effective for users.
The product was distributed without premarket approval, meaning it may not meet safety or effectiveness standards. This could lead to inaccurate results or health risks for users.
Anyone who owns or uses the Sorbitol Intolerance Test product. People with sorbitol intolerance who need testing are most at risk.
Check for the product name 'Sorbitol Intolerance Test' with EAN 616612787330 or SKU 2-B130. All lots of this product are affected.
Identify the product using the EAN 616612787330 or SKU 2-B130.
The recall record states no remedy is provided.
The product was distributed without premarket approval, which may affect its safety or effectiveness.
Look for the product name 'Sorbitol Intolerance Test' with EAN 616612787330 or SKU 2-B130. All lots are affected.
We’ve drafted a message you can send GET TESTED INTERNATIONAL AB to request your refund or repair — edit it as you like.
Subject: Recall Z-0797-2026 — GET TESTED INTERNATIONAL AB GET TESTED INTERNATIONAL AB Hello, I own a GET TESTED INTERNATIONAL AB that is covered by recall Z-0797-2026 from GET TESTED INTERNATIONAL AB. 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.