GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for 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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Food intolerance test kits are used to assess dietary intolerance. The specific device in this recall was distributed without required regulatory clearance.
The device was distributed without FDA premarket approval or clearance, signaling a regulatory noncompliance rather than a consumer-use hazard described in the notice.
This recall is not stated as part of a broader industry pattern.
Impact is regulatory and access to a potentially non-cleared diagnostic device. No injuries are described in the notice. Consumers should cease use and seek guidance from the manufacturer or clinician.
FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0806-2026
Timelines for refunds or replacements are not provided in the recall notice.
Keep the recall notice, purchase records, and any correspondence with the manufacturer. Document dates and actions taken.
Brand: GET TESTED INTERNATIONAL AB Product: Food Intolerance Test Large Quantity: 6 units Sold: US nationwide distribution Recall date: 2025-11-03 Report date: 2025-12-10 Model numbers: EAN 616612785640; SKU 1G2; UDI-DI: None; Lot/Serial Number: All Lots
No injuries or incidents have been reported.
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