MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · JHS
MAUDE profile for Differential Rate Kinetic Method, Cpk Or Isoenzymes
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Product code | JHS |
| Product code name | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Low Test Results, High Test Results, Incorrect, Inadequate or Imprecise Result or Readings, Non Reproducible Results, Use of Device Problem 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