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 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.
The recall stems from the distribution of the Allergy Test IgE without premarket approval or clearance. This poses significant health risks as the device has not undergone the necessary safety evaluations.
There have been no reported injuries or incidents associated with the Allergy Test IgE. The lack of premarket approval raises concerns about the device's safety and efficacy.
Stop using the Allergy Test IgE immediately. Patients should contact GET TESTED INTERNATIONAL AB or their healthcare provider for further instructions and follow the recall notification method provided.
To obtain further information, contact GET TESTED INTERNATIONAL AB directly. For additional support, visit the FDA's recall report page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0769-2026.
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