GET TESTED International AB recalls Organic Acids Profile Test Large due to distribution without premarket approval. All units are affected.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all units of the Organic Acids Profile Test Large product because it was distributed without proper regulatory approval. This recall does not pose an immediate safety risk but addresses regulatory compliance issues.
The product was distributed without receiving premarket approval or clearance from regulatory authorities. This means it may not meet safety or quality standards, but it does not pose a direct physical risk to users.
Anyone who purchased the Organic Acids Profile Test Large from any retailer. The risk is low as this is a regulatory compliance issue, not a safety hazard.
Check for the product name 'Organic Acids Profile Test Large' with EAN 734:221709263 or SKU UOAL. All lots of this product are affected.
Identify the product by its name, EAN number 7340221709263, or SKU UOAL.
No, this recall is due to regulatory compliance issues, not a safety hazard. The product is safe to use but must be returned as part of the recall.
Check for the product name 'Organic Acids Profile Test Large' with EAN 7340221709263 or SKU UOAL. All lots are affected.
The recall does not specify a return or disposal action, but you can contact GET TESTED International AB 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-0767-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0767-2026 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.