GET TESTED INTERNATIONAL AB recalled 12 Peptic Ulcer Tests for H. pylori sold nationwide through multiple retailers. The tests were distributed without FDA premarket approval or clearance. Health professionals and patients should stop using the tests immediately and await recall 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 product is a diagnostic test kit designed to detect Helicobacter pylori infection associated with peptic ulcers. It was distributed nationwide in the United States.
The primary hazard is distribution without FDA premarket approval or clearance, which may cast doubt on safety and effectiveness of the diagnostic results.
This recall is not part of a broader industry pattern.
Consumers and healthcare providers may rely on unvetted test results. The recall affects 12 units and requires immediate discontinuation of use.
Recall letter from the manufacturer and FDA enforcement page linked in the recall notice.
Refunds or replacements, if offered, typically take several weeks to process.
Keep the recall letter, purchase records, and correspondence with the manufacturer as part of your records.
Model numbers: EAN 616612787309; SKU 2-B220; UDI-DI: None; Lot/Serial Number: All Lots; Quantity: 12 units; Distribution: US nationwide; Sold since: Recall date 2025-11-03; Price: Unknown
No injuries or incidents have been reported.
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