MAUDE manufacturer profile
ABBOTT IRELAND · LOM
MAUDE profile for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Key facts
| Manufacturer | ABBOTT IRELAND |
|---|---|
| Manufacturer group | ABBOTT IRELAND |
| Product code | LOM |
| Product code name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Positive Result, No Known Impact Or Consequence To Patient, High Test Results, False Negative Result, No Consequences Or Impact To Patient, Low Test Results, 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