MAUDE manufacturer profile
SIEMENS HEALTHCARE DIAGNOSTICS INC. · GKL
MAUDE profile for Counter, Cell, Automated (Particle Counter)
Key facts
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Manufacturer group | THERMO FISHER SCIENTIFIC |
| Product code | GKL |
| Product code name | Counter, Cell, Automated (Particle Counter) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Incorrect, Inadequate or Imprecise Result or Readings, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Device Handling Problem, Mechanical Problem, Insufficient Information Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1