GET TESTED INTERNATIONAL AB recalls PSA Test devices distributed without premarket approval. All units are affected. No remedy specified in official notice.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB is recalling all PSA Test devices sold due to distribution without premarket approval. This means the product was not approved by regulatory authorities before being sold, which could pose safety risks.
The PSA Test devices were distributed without approval from regulatory authorities. This means the product may not meet safety standards before being sold, potentially leading to health risks if used improperly.
Anyone who purchased or uses the PSA Test device. The risk is highest for individuals relying on the device for medical testing.
Check for the product name 'PSA Test' with EAN 616612787316 or SKU G670D. All lots of this product are affected.
Identify the product using the EAN 616612787316 or SKU G670D.
The official notice does not specify any remedy for this recall.
All PSA Test devices with EAN 616612787316 or SKU G670D are affected.
The official notice does not specify a remedy, so there is no action required beyond checking if your device is affected.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0795-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0795-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
