MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · JHX
MAUDE profile for Fluorometric Method, Cpk Or Isoenzymes
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS |
| Product code | JHX |
| Product code name | Fluorometric Method, Cpk Or Isoenzymes |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, High Test Results, Low Test Results, No Consequences Or Impact To Patient, High Readings, Adverse Event Without Identified Device or Use Problem, 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