GET TESTED INTERNATIONAL AB recalled three units of its Food Allergy Panel Test (IgE) on November 3, 2025. The recall follows distribution without premarket approval. The company advises immediate cessation of use and provides further instructions for patients and healthcare providers.
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 Food Allergy Panel Test (IgE), distributed nationwide in the U.S. The affected models include EAN: 7340221709157 and SKU: U44. All lots are included in the recall.
The product was distributed without the necessary premarket approval or clearance. This poses potential risks to patient safety as the test may not meet established health standards.
No injuries or incidents have been reported related to this recall. The recall is classified as Class II, indicating a potential for harm.
Patients and healthcare providers should stop using the Food Allergy Panel Test immediately. Follow the instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB directly or visit their website. Consumers can also refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0759-2026.
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