GET TESTED International AB recalls all SIBO Test products due to distribution without premarket approval. No specific action is required as the product is not intended for medical use.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all SIBO Test products because they were distributed without proper medical approval. This means the product is not intended for medical use and no action is needed.
The product was distributed without premarket approval from regulatory authorities. This means it was not tested or approved for medical use before being sold. As a result, it is not intended for medical purposes and poses no health risk.
Anyone who purchased the SIBO Test product from a retailer. The product is not intended for medical use, so most people are not at risk.
Check for the product name 'SIBO Test' with EAN 616612785947 or SKU B105. All lots of this product are affected.
Look for the product name 'SIBO Test' with EAN 616612785947 or SKU B105.
No, the product is not intended for medical use and was distributed without premarket approval. It is not safe for medical purposes.
No action is required as the product is not intended for medical use.
The product was distributed without premarket approval, so it is not intended for medical use and poses no health risk.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0796-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0796-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
