GET TESTED International AB recalls all NAD Profile Test devices due to distribution without premarket approval. Consumers should contact the manufacturer for details.
Distribution without premarket approval/clearance.
GET TESTED International AB is recalling all NAD Profile Test devices because they were distributed without proper premarket approval. This recall does not pose an immediate safety risk but requires consumers to verify their product and contact the manufacturer.
The device was distributed without premarket approval, meaning it hasn't been tested or approved by regulatory authorities for safety and effectiveness. This could lead to inaccurate test results or potential health risks if used improperly.
All owners of the NAD Profile Test device are affected. Individuals using the device for medical testing are most at risk due to the lack of regulatory approval.
Check for the EAN number 7340221709270 or SKU UNAD on the device. All lots of the NAD Profile Test are affected.
Verify the EAN number 7340221709270 or SKU UNAD on the device to confirm it is recalled.
The recall indicates the device was distributed without premarket approval, so it may not be safe for use. Consult the manufacturer for details.
All lots of the NAD Profile Test are affected. Check for the EAN number 7340221709270 or SKU UNAD on the device.
Contact GET TESTED International AB for further instructions. The recall does not specify a return or disposal action.
We’ve drafted a message you can send GET TESTED to request your refund or repair — edit it as you like.
Subject: Recall Z-0766-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0766-2026 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.
