FDA-Device2025-12-10Class IIMISBRANDING
Syphilis Test
Hazard
Distribution without premarket approval/clearance.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
528 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Syphilis Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0751-2026Want us to check the next one for you?
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