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Recall Category: Medical Device Recalls
Recalling Firm: GET TESTED INTERNATIONAL AB
Product: Food Intolerance Test Small
Reason for Recall: Distribution without premarket approval/clearance.
Classification: Class II
Status: Ongoing
Report Date: 12/10/2025
Recall Initiation Date: 11/03/2025
Distribution: US Nationwide distribution.
Code Info: EAN: 616612785626; SKU: 1G1; UDI-DI: None; Lot/Serial Number: All Lots;
Product Quantity: 5 units
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: Letter
Firm Location: Vastervik, Sweden
Recall Number: Z-0808-2026
Event ID: 97896