GET TESTED International AB recalls all sperm 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 sperm tests sold in the U.S. because they were distributed without proper regulatory approval. This recall does not involve immediate safety risks but requires consumers to verify their product and contact the company.
The sperm tests were distributed without receiving premarket approval or clearance from regulatory authorities. This means the product may not meet safety or quality standards, though it does not pose an immediate physical risk.
Anyone who purchased a sperm test from GET TESTED International AB. The recall affects all units sold, but there is no specific group at higher risk.
Check for the product name 'Sperm Test' with EAN 7340221710221 or SKU VAN-SPE. All lots of this product are affected.
Look for the EAN 7340221710221 or SKU VAN-SPE on the product label.
No, the recall is due to distribution without premarket approval, not an immediate safety hazard.
All sperm tests with EAN 7340221710221 or SKU VAN-SPE are affected.
Contact GET TESTED International AB for guidance on next steps.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0757-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0757-2026 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.
