MAUDE manufacturer profile
ABBOTT IRELAND · DHX
MAUDE profile for System, Test, Carcinoembryonic Antigen
Key facts
| Manufacturer | ABBOTT IRELAND |
|---|---|
| Manufacturer group | ABBOTT IRELAND |
| Product code | DHX |
| Product code name | System, Test, Carcinoembryonic Antigen |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Low Test Results, High Test Results, No Known Impact Or Consequence To Patient, No Code Available, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, 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