GET TESTED INTERNATIONAL AB recalls Women's Hormone Test products distributed without premarket approval. Consumers should check product details and contact the company for guidance.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB has recalled all Women's Hormone Test products 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 for safety and effectiveness before being sold. This could lead to potential health risks if the product is not properly regulated.
Anyone who purchased the Women's Hormone Test product from any retailer. Women seeking hormone testing are most at risk.
Check for the product name 'Women s Hormone Test' with EAN 616612786999 or SKU O935. All lots of this product are affected.
Identify the product using the EAN 616612786999 or SKU O935.
The recall indicates the product was distributed without premarket approval, but the official notice does not specify if it is safe to use.
The official recall notice does not mention any replacement options.
The official notice does not specify a remedy, so contact GET TESTED INTERNATIONAL AB for guidance.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0798-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0798-2026 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.
