MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · LTJ
MAUDE profile for Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS |
| Product code | LTJ |
| Product code name | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Low Test Results, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient 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