Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA adverse event reports and recall history for kit, test, alpha-fetoprotein for neural tube defects (product code LOK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 158
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 155
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2003-07-24TerminatedOther
AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
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