MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · KLT
MAUDE profile for Enzyme Immunoassay, Carbamazepine
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Product code | KLT |
| Product code name | Enzyme Immunoassay, Carbamazepine |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- High Test Results, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Low Test Results, Incorrect Measurement 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