MAUDE manufacturer profile
ABBOTT POINT OF CARE · GJS
MAUDE profile for Test, Time, Prothrombin
Key facts
| Manufacturer | ABBOTT POINT OF CARE |
|---|---|
| Manufacturer group | ABBOTT POINT OF CARE CANADA LTD. |
| Product code | GJS |
| Product code name | Test, Time, Prothrombin |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Incorrect, Inadequate or Imprecise Result or Readings, No Information, No Clinical Signs, Symptoms or Conditions, Atrial Fibrillation, Pulmonary Embolism, False Positive Result, Thrombosis/Thrombus, Stroke/CVA 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