GET TESTED International AB recalls all 8 in 1 STI Test Kits sold 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 all 8 in :1 STI Test Kits sold because they were distributed without proper regulatory approval. This means the products may not meet safety standards and could pose risks.
The test kits were distributed without premarket approval, meaning they weren't tested or approved by regulatory authorities before being sold. This could lead to the products not meeting safety standards and potentially causing harm if used incorrectly.
Anyone who purchased the 8 in 1 STI Test Kit from any retailer. People using the test kit for medical testing are most at risk due to potential safety issues.
Check for the product name '8 in 1 STI Test Kit', EAN code 7340221704794, or SKU JD-8STI. All lots of this product are affected.
Look for the EAN code 7340221704794 or SKU JD-8STI on the product label.
The product was distributed without premarket approval, meaning it wasn't tested or approved by regulatory authorities before being sold.
Check for the product name '8 in 1 STI Test Kit', EAN code 7340221704794, or SKU JD-8STI. All lots of this product are affected.
The official recall notice does not specify a remedy or action for affected consumers.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0818-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0818-2026 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.