GET TESTED International AB recalls all Diabetes HbA1c 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 Diabetes HbA1c Tests sold because they were distributed without proper regulatory approval. This could pose risks if used without proper testing protocols.
The test was distributed without premarket approval, meaning it may not meet safety and effectiveness standards set by regulatory authorities. This could lead to inaccurate results if used without proper oversight.
People who own or use the Diabetes HbA1c Test from GET TESTED International AB are affected. Those with diabetes who rely on this test for monitoring are at higher risk.
Check for the EAN number 7340221707191 or SKU A-HbA1c on the test packaging. All lots of this product are affected.
Look for the EAN 7340221707191 or SKU A-HbA1c on the test packaging to confirm if it's recalled.
The recall is due to distribution without premarket approval, not an immediate safety risk. The official notice does not specify if the test is dangerous to use.
The official notice does not mention replacement options or remedies.
The official notice does not specify actions beyond checking product details. Contact GET TESTED International AB for further 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-0732-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0732-2026 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.
