MAUDE manufacturer profile
BIO-RAD MEDICAL DIAGNOSTICS GMBH · KSZ
MAUDE profile for System, Test, Automated Blood Grouping And Antibody
Key facts
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
|---|---|
| Manufacturer group | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Product code | KSZ |
| Product code name | System, Test, Automated Blood Grouping And Antibody |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, False Negative Result, False Positive Result, No Clinical Signs, Symptoms or Conditions, Defective Component, Incorrect, Inadequate or Imprecise Result or Readings, Defective Device, No Consequences Or Impact To Patient 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