MAUDE manufacturer profile
ROCHE DIAGNOSTICS · LOM
MAUDE profile for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | ROCHE DIAGNOSTICS GMBH |
| Product code | LOM |
| Product code name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
At a glance
- 100–999 MAUDE reports
- 100–999 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, Non Reproducible Results, False Negative Result, High Test Results, Low Test Results, Incorrect, Inadequate or Imprecise Result or Readings 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