MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · JJE
MAUDE profile for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Product code | JJE |
| Product code name | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ 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, Nonstandard Device, No Consequences Or Impact To Patient, Incorrect Or Inadequate Test Results 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