GET TESTED International AB recalls alcohol saliva test devices due to distribution without premarket approval. All units are affected. No specific action steps provided in recall notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all alcohol saliva test devices because they were distributed without proper regulatory approval. This means the products may not be safe for use as intended.
The products were distributed without premarket approval, meaning they were not tested or approved by regulatory authorities before being sold. This could lead to inaccurate results or safety issues if the tests are used improperly.
Anyone who purchased or uses the alcohol saliva test devices. The risk is highest for individuals relying on these tests for medical or legal purposes.
The product is labeled as 'Alcohol (ALC) Test Saliva' with EAN 7340221708884 or SKU A-ALC-S. All lots of this product are affected.
Identify the product by its EAN number (7340221708884) or SKU (A-ALC-S).
The products were distributed without premarket approval, meaning they were not tested or approved by regulatory authorities before being sold.
The recall notice does not specify any action steps for affected products.
The recall notice does not describe any specific hazard that could cause injury.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0727-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0727-2026 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.
