GET TESTED International AB recalls blood type test kits distributed without premarket approval. All units are affected. No remedy provided in official notice.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all blood type test kits sold due to distribution without premarket approval. This means the tests may not be safe or effective as intended.
Blood type tests distributed without premarket approval may not meet safety or effectiveness standards. This could lead to inaccurate results or health risks if used improperly.
Anyone who purchased a blood type test kit from GET TESTED International AB. People using these tests for medical purposes are most at risk.
Check for the product name 'Blood Type Test' with EAN 7340221708136 or SKU A-BG. All lots are affected.
Identify the product using the EAN 7340221708136 or SKU A-BG.
The official notice does not provide a remedy.
Look for the product name 'Blood Type Test' with EAN 7340221708136 or SKU A-BG. All lots are affected.
The tests were distributed without premarket approval, which may mean they are not safe or effective as intended.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0728-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0728-2026 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.
