GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device immediately and follow manufacturer 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 Pollen Allergy Test is designed for individuals to test for pollen allergies. Consumers typically purchase such tests to identify specific allergens and manage their symptoms effectively.
The hazard stems from the lack of premarket approval, which means the product has not undergone necessary safety and efficacy evaluations. This raises concerns about its reliability and potential health risks during use.
This recall is not part of a broader industry pattern.
The recall requires consumers to stop using the product immediately, which may cause inconvenience and necessitate seeking alternative testing methods.
Model numbers can typically be found on the product packaging or instruction manual.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep records of your purchase, including receipts and correspondence with the manufacturer.
The recalled Pollen Allergy Test has model numbers EAN: 616612785688 and SKU: 1EP. It was distributed nationwide in the U.S. All lots of the product are affected.
Not sure what to do next? Our guide walks you through the process step by step.
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