Abbott Diagnostics Division/celldyn
FDA adverse event reports naming Abbott Diagnostics Division/celldyn as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT DIAGNOSTICS DIVISION/CELLDYN.
- Total reports
- 1,704
- Deaths
- 4
- Injuries
- 32
- Malfunctions
- 1,304
Reports per year
597
1598
1899
1800
1601
502
3803
6004
5705
7506
18907
72008
36709
12110
Source: FDA adverse event reports by year received, 1997–2010. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Counter, Differential CellGKZ1,609
- Counter, Cell, Automated (Particle Counter)GKL38
- Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE33
- Calibrator For Hemoglobin And Hematocrit MeasurementKRZ10
- Mixture, Hematology Quality ControlJPK5
- Spinner, Slide, AutomatedGKJ3
- Diluent, Blood CellGIF2
- Control, Cell Counter, Normal And AbnormalJCN2
- Electrode, NeedleGXZ1
- DetergentJCB1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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