GET TESTED INTERNATIONAL AB recalls all Female Fertility Tests due to distribution 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 Female Fertility Tests sold under the EAN 7340221707139. The recall is due to the product being distributed without proper regulatory approval, which could pose safety risks.
The product was distributed without premarket approval, meaning it hasn't been tested or approved by regulatory authorities for safety and effectiveness. This could lead to inaccurate results or potential health risks if used improperly.
Anyone who purchased the Female Fertility Test with EAN 734:0221707139. Women using the test for fertility purposes are most at risk due to the lack of regulatory approval.
Check for the EAN code 7340221707139 on the product label. The product is sold under SKU A-AMH and includes all lots.
Look for the EAN code 7340221707139 on the product label to confirm if it's affected.
The product was distributed without premarket approval, meaning it hasn't been tested or approved by regulatory authorities for safety and effectiveness.
Check for the EAN code 7340221707139 on the product label. The product is sold under SKU A-AMH and includes all lots.
The recall record 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-0737-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0737-2026 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.