Bio-detek Incorporated
FDA adverse event reports naming Bio-detek Incorporated as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIO-DETEK INCORPORATED.
- Total reports
- 1,630
- Deaths
- 64
- Injuries
- 204
- Malfunctions
- 1,361
Reports per year
12215
14616
14017
10118
16319
10620
14621
16722
16123
10624
18925
8326
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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