FDA-Device2025-12-10Class IIMISBRANDING
Diabetes HbA1c Test
Hazard
Distribution without premarket approval/clearance.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
148 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Diabetes HbA1c Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0732-2026Don't want to check this manually?
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