MAUDE manufacturer profile
ROCHE DIAGNOSTICS · LOL
MAUDE profile for Hepatitis A Test (Antibody And Igm Antibody)
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | LOL |
| Product code name | Hepatitis A Test (Antibody And Igm Antibody) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Positive Result, No Consequences Or Impact To Patient, False Negative Result, Non Reproducible Results, No Known Impact Or Consequence To Patient, High Test Results, Output 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