GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.
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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The Allergy Test IgE is designed to detect specific IgE antibodies associated with allergic reactions. Consumers may purchase this test to identify potential allergens affecting their health.
The hazard arises from distributing the Allergy Test IgE without premarket approval, meaning it has not been evaluated for safety and effectiveness by regulatory authorities.
This recall is not part of a broader industry pattern.
Consumers using this device may face potential health risks due to the lack of safety evaluation, which can lead to misdiagnosis or ineffective allergy management.
Serial numbers, lot numbers, and other identifiers can usually be found on the product packaging or accompanying documentation.
Expect a response regarding refunds or further instructions within 4-6 weeks after contacting the manufacturer.
Keep records of your purchase, communication with the manufacturer, and any health symptoms related to the use of the device.
The Allergy Test IgE carries the SKU HT-IgE and EAN 7340221707221. It has no specific UDI-DI and all lots are affected. The product was distributed nationwide across the United States.
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