MAUDE manufacturer profile
ORTHO-CLINICAL DIAGNOSTICS, INC. · KSZ
MAUDE profile for System, Test, Automated Blood Grouping And Antibody
Key facts
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Product code | KSZ |
| Product code name | System, Test, Automated Blood Grouping And Antibody |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Incorrect, Inadequate or Imprecise Result or Readings, False Negative Result, No Clinical Signs, Symptoms or Conditions, Incorrect Or Inadequate Test Results, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Device Operates Differently Than Expected 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