GET TESTED International AB recalls gonorrhea tests 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 gonorrhea tests due to distribution without premarket approval. This means the tests may not meet safety standards before being sold.
The tests were distributed without premarket approval, meaning they were not reviewed by health authorities before being sold. This could lead to potential safety issues if the tests are not properly validated.
People who purchased the gonorrhea test kits from retailers or online. Those who use the tests for self-testing may be at risk if the product was distributed without proper approval.
Check for the EAN number 7340221701533 or SKU A-IGO on the product packaging. All lots of this product are affected.
Look for the EAN 7340221701533 or SKU A-IGO on the packaging to confirm if you have the recalled product.
The product was distributed without premarket approval, meaning it was not reviewed by health authorities before being sold.
Check for the EAN number 7340221701533 or SKU A-IGO on the packaging. All lots of this product are affected.
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-0738-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0738-2026 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.
