GET TESTED INTERNATIONAL AB recalls Neurotransmitters Basic 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 Basic devices because they were distributed without proper regulatory approval. This could pose safety risks if the product is used without meeting required safety standards.
The product was distributed without premarket approval, meaning it may not meet safety standards required by regulatory authorities. This could lead to potential safety issues if the device is used without proper testing and validation.
Anyone who owns or uses Neurotransmitters Basic devices. The risk is higher for users who rely on these devices for medical purposes.
Check for the product name 'Neurotransmitters Basic' with EAN 616612786432 or SKU F500. All lots of this product are affected.
Identify the product by its EAN number 616612786432 or SKU F500.
The recall record states the product was distributed without premarket approval, but does not confirm if it is safe to use. The manufacturer has not provided specific safety information.
Check for the EAN number 616612786432 or SKU F500 on the product label. All lots of this product are affected.
The recall record does not specify a remedy, so there is no action required beyond checking if your product is 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-0789-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0789-2026 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.
