GET TESTED INTERNATIONAL AB recalled 2 units of its Mycotoxin Panel Test on November 3, 2025. The recall follows distribution without necessary premarket approval. Consumers must stop using the product immediately and follow the provided 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 Mycotoxin Panel Test is classified as a Class II medical device. It was distributed nationwide in the United States. The affected model includes EAN: 7340221709300, SKU: UMT, with all lots involved in the recall.
The product was distributed without premarket approval or clearance from the FDA. This poses a significant risk to patient safety due to the lack of regulatory oversight.
There are no reported injuries or incidents associated with this recall. The lack of premarket approval heightens the risk of unverified health claims.
Patients and healthcare providers should stop using the Mycotoxin Panel Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions and follow the recall notification.
Consumers can contact GET TESTED INTERNATIONAL AB for more information. Visit the official website or refer to the FDA's recall page for details.
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