MAUDE manufacturer profile
ABBOTT DIAGNOSTICS SCARBOROUGH, INC · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | ABBOTT DIAGNOSTICS SCARBOROUGH, INC |
|---|---|
| Manufacturer group | ABBOTT DIAGNOSTICS SCARBOROUGH, INC |
| Product code | QKP |
| Product code name | Coronavirus Antigen Detection Test System. |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Negative Result, False Positive Result, Non Reproducible Results, Insufficient Information, Use of Device Problem, Improper or Incorrect Procedure or Method, No Apparent Adverse Event 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