Biosite Incorporated
FDA adverse event reports naming Biosite Incorporated as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOSITE INCORPORATED.
- Total reports
- 2,140
- Deaths
- 3
- Injuries
- 254
- Malfunctions
- 1,850
Reports per year
207
2908
96709
1,13110
412
714
Source: FDA adverse event reports by year received, 2007–2014. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Multipurpose For In Vitro Coagulation StudiesJPA975
- Test, Time, ProthrombinGJS746
- Immunoassay Method, Troponin SubunitMMI213
- Visual, Pregnancy Hcg, Prescription UseJHI138
- Test, Natriuretic PeptideNBC40
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP6
- Kit, Test, Pregnancy, Hcg, Over The CounterLCX4
- Enzyme Immunoassay, MethadoneDJR3
- Colorimetric Method, Lecithin/Sphingomyelin RatioJHF3
- Fluorometer, For Clinical UseKHO3
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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