GET TESTED International AB recalls 5-test ovulation kits 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 is recalling 5-test ovulation kits because they were distributed without proper regulatory approval. This recall does not involve immediate safety risks but requires consumers to check their product details and contact the company for instructions.
The kits were distributed without premarket approval, meaning they were not tested or approved by regulatory authorities before being sold. This could lead to inaccurate results or potential health risks if the product does not meet safety standards.
Anyone who purchased the 5-test ovulation kit from retailers. Women using the kit for fertility tracking are most at risk if they have unapproved products.
Check for the EAN number 7340221700451 or SKU A-LH on the product packaging. All lots of this 5-test ovulation kit are affected.
Look for the EAN 7340221700451 or SKU A-LH on the packaging to confirm if your kit is recalled.
The recall is due to distribution without premarket approval, not an immediate safety hazard. The company recommends checking product details and contacting them for guidance.
Check the product packaging for the EAN number 7340221700451 or SKU A-LH. All lots of this 5-test ovulation kit are affected.
Contact GET TESTED International AB directly for instructions on what to do next.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0747-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0747-2026 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.