MTNClass N
Test, Syphilis, Treponemal
FDA adverse event reports and recall history for test, syphilis, treponemal (product code MTN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 104
- Deaths
- 0
- Injuries
- 15
- Malfunctions
- 89
Reports per year
1716
2617
2218
3919
Source: FDA adverse event reports by year received, 2016–2019. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-01Open, ClassifiedNo Marketing Application
Syphilis Test
Distribution without premarket approval/clearance.
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