GET TESTED International AB recalls all Continuous Glucose Monitors (CGM) sold without premarket approval. This affects users who may not have received necessary safety reviews before use.
Distribution without premarket approval/clearance.
GET TESTED International AB has recalled all Continuous Glucose Monitors (CG:CGM-15D) sold without premarket approval. This means the devices were distributed without proper safety reviews, which could pose risks to users.
The devices were distributed without premarket approval, meaning they weren't tested for safety before being sold. This could lead to potential issues with how the monitors function, especially for people who depend on them for accurate blood sugar readings.
People who own or use the GET TESTED Continuous Glucose Monitors (CGM-15D) are affected. Those with diabetes who rely on these monitors for blood sugar tracking are at the highest risk.
Check for the product name 'Continuous Glucose Monitor (CGM)' and the SKU 'CGM-15D'. The devices were sold without premarket approval and are available across all lots.
Look for the SKU 'CGM-15D' and EAN '7340221708952' to confirm if your device is affected.
The devices were distributed without premarket approval, meaning they weren't tested for safety before being sold.
The official notice does not specify a remedy or action for affected users.
The recall states the devices were distributed without premarket approval, but no specific safety risks are described.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0770-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0770-2026 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.
