MAUDE manufacturer profile
ROCHE DIAGNOSTICS · DHX
MAUDE profile for System, Test, Carcinoembryonic Antigen
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | DHX |
| Product code name | System, Test, Carcinoembryonic Antigen |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- High Test Results, No Clinical Signs, Symptoms or Conditions, Low Test Results, No Consequences Or Impact To Patient, Non Reproducible Results, No Known Impact Or Consequence To Patient, Incorrect Measurement, Incorrect, Inadequate or Imprecise Result or Readings 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