FDA-Device2025-12-10Class IIMISBRANDING

Akkermansia Test

FALSE CLAIMSNationwide distributiondevice
Hazard

Distribution without premarket approval/clearance.

Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
24 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Akkermansia Test

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0773-2026

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