GET TESTED INTERNATIONAL AB recalled 76 units of its Allergy Test on November 3, 2025. The recall occurred due to distribution without premarket approval. 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 recalled product is the Allergy Test Small by GET TESTED INTERNATIONAL AB. It includes models EAN: 616612785602 and SKU: 1CO. The product was distributed nationwide in the U.S.
The product was distributed without the necessary premarket approval or clearance, which poses a significant risk of ineffective or unsafe testing. The FDA classified this recall as Class II, indicating a moderate risk.
There have been no reported incidents or injuries associated with the use of this product. The recall is a precautionary measure.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB for further guidance.
For further information, contact GET TESTED INTERNATIONAL AB or your healthcare provider. Refer to the recall notification letter for specific instructions.
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