MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · DHA
MAUDE profile for System, Test, Human Chorionic Gonadotropin
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS |
| Product code | DHA |
| Product code name | System, Test, Human Chorionic Gonadotropin |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, High Test Results, No Clinical Signs, Symptoms or Conditions, Low Test Results, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient, Non Reproducible Results, Nonstandard Device 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