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 Allergy Test Small by GET TESTED INTERNATIONAL AB is designed for allergy testing. Consumers typically purchase it to identify potential allergens that may cause reactions.
The device's distribution without premarket approval means it has not undergone necessary safety and efficacy evaluations. This raises concerns about its reliability and potential health risks.
This recall is not part of a broader industry pattern.
Consumers must stop using the product to avoid potential health risks. The recall does not appear to have caused any reported injuries, but it is crucial to act quickly.
The model number can typically be found on the product packaging or the device itself.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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.
Not sure what to do next? Our guide walks you through the process step by step.
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