GET TESTED International AB recalls Lyme Test devices distributed 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 Lyme Test devices due to being distributed without proper premarket approval. This means the product may not meet safety standards before being sold.
The Lyme Test devices were distributed without premarket approval, meaning they were not tested for safety and effectiveness before being sold. This could lead to inaccurate results or health risks if used improperly.
Anyone who purchased the Lyme Test device from a retailer. People using the device for Lyme disease testing are most at risk.
Check for the product name 'Lyme Test' with EAN 7340221700468 or SKU A-ILY. All lots of this product are affected.
Look for the EAN 7340221700468 or SKU A-ILY on the device packaging.
The recall is due to distribution without premarket approval, but the official notice does not specify if the product is dangerous.
Check for the EAN 7340221700468 or SKU A-ILY on the device packaging.
The official recall notice does not specify a remedy, so contact GET TESTED International AB for 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-0743-2026 — GET TESTED GET TESTED Hello, I own a GET TESTED that is covered by recall Z-0743-2026 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.
