GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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This product is a medical device intended for health monitoring or diagnostic use. Consumers may purchase such devices for personal health management or medical needs.
The hazard arises from the product's distribution without the required premarket approval, meaning it has not been evaluated for safety or effectiveness by regulatory authorities.
This recall is not part of a broader industry pattern.
Consumers may face health risks from using this unapproved device, leading to potential misdiagnosis or ineffective treatment options.
The EAN is typically found on the product packaging or the device itself, often near the barcode.
Refund or replacement processing timelines may vary; expect 4-8 weeks for resolution.
Keep all correspondence regarding the recall, including letters and emails, as well as any receipts or proof of purchase.
The recalled product is identified by EAN: 7340221701083 and SKU: A-DR12. It has no specific lot or serial number as all lots are affected. The product was distributed nationwide in the United States.
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