MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS · QKO
MAUDE profile for Reagent, Coronavirus Serological
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS |
| Product code | QKO |
| Product code name | Reagent, Coronavirus Serological |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Incorrect, Inadequate or Imprecise Result or Readings, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, False Positive Result, No Consequences Or Impact To Patient, False Negative Result, Insufficient Information, Manufacturing, Packaging or Shipping Problem 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