FDA-Device2025-12-10Class IIMISBRANDING
Fecal Occult Blood Test
Hazard
Distribution without premarket approval/clearance.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
35 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Fecal Occult Blood Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2026Want us to check the next one for you?
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