GET TESTED International AB recalls all allergy and food intolerance test kits due to distribution without premarket approval. No specific action is required as the product is not regulated.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all allergy and food intolerance test kits because they were distributed without proper regulatory approval. This means the product may not meet safety standards, but no immediate action is needed as the recall does not require stopping use.
The tests were distributed without premarket approval, meaning they were not reviewed by regulators for safety and effectiveness before being sold. This could lead to inaccurate results or potential health risks if the tests are not reliable.
Anyone who purchased the allergy or food intolerance test kits from any retailer. People with allergies or food sensitivities are most at risk if they use the tests without proper approval.
Check for the product name 'Allergy & Food Intolerance Test' with EAN 616612785497 or SKU 1B2. All lots of this product are affected.
Look for the EAN 616612785497 or SKU 1B2 on the test kit packaging.
No, the recall does not require stopping use. The product is not regulated, but it may not be safe.
The official notice does not mention any fix or remedy for this product.
Check the EAN 616612785497 or SKU 1B2 on the packaging. All lots of this product 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-0802-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0802-2026 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.
