GET TESTED INTERNATIONAL AB recalls Neurotransmitters XL devices due to distribution without premarket approval. All units are affected and should be checked for safety.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling all Neurotransmitters XL devices because they were distributed without proper regulatory approval. This could pose safety risks if the devices are used without being cleared by authorities.
The devices were distributed without premarket approval or clearance from regulatory authorities. This means they may not meet safety standards, potentially leading to risks if used without proper oversight.
Anyone who owns or uses Neurotransmitters XL devices. The risk is highest for users who may not be aware of the regulatory status of the product.
Check for the product name 'Neurotransmitters XL' and the EAN number 616612786968. All units are affected regardless of lot or serial number.
Identify the product by checking the EAN number 616612786968 or SKU F620.
The devices were distributed without premarket approval or clearance from regulatory authorities.
Look for the product name 'Neurotransmitters XL' and the EAN number 616612786968. All units are affected.
The recall record does not specify a remedy, so check with the manufacturer for further instructions.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0791-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0791-2026 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.
