GET TESTED International AB recalls Food Sensitivity Test Medium due to distribution without premarket approval. All lots are affected. No remedy provided in official notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Food Sensitivity Test Medium products because they were distributed without proper premarket approval. This means the product may not be safe for use as intended.
The product was distributed without premarket approval, meaning it may not have undergone required safety testing. This could lead to potential health risks if used without proper validation.
Anyone who purchased the Food Sensitivity Test Medium product. People using the product for medical testing may be at risk due to unapproved distribution.
Check for the product name 'Food Sensitivity Test Medium' with EAN 7340221709171 or SKU U144. All lots are affected, so no specific lot or serial numbers are needed.
Look for the product name 'Food Sensitivity Test Medium' with EAN 7340221709171 or SKU U144.
The official notice does not provide a remedy.
The official notice does not specify any action steps.
The official notice states the product was distributed without premarket approval, so safety is not 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-0761-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0761-2026 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.
