GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s 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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Akkermansia Test is described as a diagnostic tool related to gut microbiome analysis from GET TESTED INTERNATIONAL AB.
The hazard stems from distributing a medical device without required premarket approval, potentially affecting safety and effectiveness.
This recall is not described as part of a broader industry pattern.
Consumers may be left with unusable results or delayed care if relying on this test; immediate action is required to prevent potential harm.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0773-2026
Refunds or replacements, if offered, typically take 4-6 weeks after verification
Save the recall letter, FDA notice, and any correspondence with the manufacturer. Photograph packaging and serial numbers for your records
Brand: GET TESTED INTERNATIONAL AB Product: Akkermansia Test Model numbers: EAN 616612787187; SKU 2A171; UDI-DI: None; Lot/Serial Number: All Lots Sold in: United States nationwide When sold: Unknown Price: Unknown Quantity: 24 units
No injuries or incidents have been reported.
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