MAUDE manufacturer profile
ROCHE DIAGNOSTICS · LFX
MAUDE profile for Enzyme Linked Immunoabsorbent Assay, Rubella
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | LFX |
| Product code name | Enzyme Linked Immunoabsorbent Assay, Rubella |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- High Test Results, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Low Test Results, No Known Impact Or Consequence To Patient, False Negative Result, False Positive Result, 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