MAUDE manufacturer profile
ABBOTT IRELAND · KSJ
MAUDE profile for System, Identification, Hepatitis B Antigen
Key facts
| Manufacturer | ABBOTT IRELAND |
|---|---|
| Manufacturer group | ABBOTT IRELAND |
| Product code | KSJ |
| Product code name | System, Identification, Hepatitis B Antigen |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, False Positive Result, False Negative Result, No Consequences Or Impact To Patient, High Test Results, Incorrect Or Inadequate Test Results, Low Test Results, No Code Available 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