GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB for instructions.
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 Small device is a diagnostic product intended to assess allergies. It is distributed for use in clinical or consumer settings.
The hazard stems from distribution without FDA premarket approval or clearance, creating regulatory noncompliance and potential questions about device validity.
This recall is not described as part of a broader industry pattern.
No injuries reported. The primary impact is regulatory risk and the need for healthcare providers and patients to stop use until further instructions are issued.
Labels on the device and accompanying documentation should include the model and lot information.
4-6 weeks for refund or replacement processes if offered; exact timing not stated in recall.
Keep the recall notice, product packaging, photos of labels, and any correspondence with the manufacturer.
Model numbers: EAN 616612785503; SKU 1000; UDI-DI: None; Lot/Serial Number: All Lots. Sold: United States nationwide. Price: Unknown.
No injuries or incidents have been reported.
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