GET TESTED International AB recalls Gut Microbi:ome Test Mega products distributed without premarket approval. Consumers should check product details for recall.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled their Gut Microbiome Test Mega product due to distribution without premarket approval. This means the product was not approved by regulatory authorities before being sold.
The product was distributed without premarket approval, meaning it was not reviewed by regulatory authorities before being sold. This could lead to potential safety or efficacy issues not addressed during the approval process.
Anyone who purchased the Gut Microbiome Test Mega product from any retailer. The risk is primarily for consumers using the test without regulatory approval.
Check for the product name 'Gut Microbiome Test Mega' with EAN 616612786944 or SKU 2A713BWG-A500. All lots of this product are affected.
Identify the product by its EAN number 616612786944 or SKU 2A713BWG-A500.
The recall states the product was distributed without premarket approval, but does not specify if it is safe to use.
Check for the product name 'Gut Microbiome Test Mega' with EAN 616612786944 or SKU 2A713BWG-A500.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0780-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0780-2026 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.
