FDA-Device2025-12-10Class IIMISBRANDING
Kidney Test
Hazard
Distribution without premarket approval/clearance.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
100 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Kidney Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0800-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.