GET TESTED INTERNATIONAL AB recalled 24 Akkermansia Tests on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately.
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 Akkermansia Test is classified as a Class II medical device. A total of 24 units were distributed nationwide in the US.
The Akkermansia Test was distributed without the necessary premarket approval or clearance. This raises concerns over safety and efficacy, impacting patients relying on this device.
No incidents or injuries have been reported related to this recall. The lack of premarket approval poses a significant concern for patient safety.
Patients and healthcare providers should stop using the Akkermansia Test immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0773-2026.
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