GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must 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 Pet Allergy Test with model identifiers EAN: 616612785695, SKU: TI. It was distributed nationwide in the U.S. and is classified as a Class II medical device.
The recall stems from the distribution of the Pet Allergy Test without the necessary premarket approval or clearance. This lack of regulation may pose health risks to users.
No specific incidents or injuries have been reported related to this recall. The recall is precautionary due to the lack of regulatory approval.
Patients and healthcare providers should stop using the Pet Allergy Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For more information, contact GET TESTED INTERNATIONAL AB. Visit their website or refer to the recall notice provided.
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