GET TESTED International AB recalls diabetes test kits (ketones & glucose) distributed without premarket approval. All lots affected. No remedy provided in official recall.
Distribution without premarket approval/clearance.
GET TESTED International AB is recalling all diabetes test kits for ketones and glucose due to distribution without premarket approval. This means the products were not approved by health authorities before being sold, potentially posing safety risks.
The tests were distributed without approval from health authorities, meaning they may not meet safety standards. This could lead to inaccurate results or other health risks if used improperly.
People who own or use GET TESTED diabetes test kits for ketones and glucose are affected. Those with diabetes who rely on these tests for monitoring are at risk.
Check for the product name 'Diabetes Test (ketones & glucose)' on the packaging. All lots are affected, so no specific lot or serial number is needed.
Look for the product name 'Diabetes Test (ket:ones & glucose)' on the packaging.
The product was distributed without premarket approval from health authorities, meaning it may not meet safety standards.
The official recall does not provide a remedy.
All lots of the diabetes test kits for ketones and glucose are 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-0799-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0799-2026 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.
