GET TESTED International AB recalls melatonin test kits due to distribution without premarket approval. All lots affected. No specific remedy provided in official notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all melatonin test kits sold because they were distributed without proper regulatory approval. This means the products may not be safe or effective for use.
The melatonin test kits were distributed without receiving premarket approval or clearance from regulatory authorities. This could mean the products lack necessary safety and effectiveness testing, potentially leading to inaccurate results or health risks.
Anyone who purchased the melatonin test kits from any retailer. People using these kits for medical testing may be at risk due to unapproved distribution.
Check for the EAN number 616612785657 or SKU 1ML on the product packaging. All lots of this melatonin test kit are affected.
Look for the EAN 616612785657 or SKU 1ML on the product packaging to confirm it is the recalled item.
The melatonin test kits were distributed without premarket approval or clearance from regulatory authorities.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates the products may not be safe or effective due to lack of regulatory approval, but specific risks are not detailed in the notice.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0812-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0812-2026 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.
