GET TESTED INTERNATIONAL AB recalled 3 units of its Food Allergy Panel Test (IgE) distributed nationwide in the United States after distribution without premarket approval was identified. The recall pertains to a regulatory lapse rather than an announced safety defect. Consumers 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 Food Allergy Panel Test (IgE) is a diagnostic tool used to screen for multiple food allergies in a single assay. It is distributed by GET TESTED INTERNATIONAL AB and marketed in the United States.
The recall revolves around distribution without FDA premarket approval or clearance, meaning the product may not have undergone proper regulatory evaluation for safety and effectiveness.
This recall is not part of a broader industry pattern.
Consumers who own the kit should halt use and seek guidance from a healthcare professional. The recall could affect diagnostic decision-making if the kit was used to influence care.
Identifiers are on packaging labeling. The EAN is 7340221709157. The SKU is U44. Lot/serial number is All Lots.
Refunds or replacements follow the manufacturer recall process. Processing may take 4-6 weeks after verification.
Keep the recall letter, packaging, photos of labeling, and all correspondence. Save receipts or proof of purchase if available.
Brand: GET TESTED INTERNATIONAL AB Product: Food Allergy Panel Test (IgE) Models: EAN 7340221709157; SKU U44; UDI-DI: None; Lot/Serial Number: All Lots Quantity recalled: 3 units Sold in the U.S.: Nationwide distribution Recall date: 2025-11-03 Price: Unknown
No injuries or incidents have been reported.
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