MAUDE manufacturer profile
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG · QHO
MAUDE profile for Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
Key facts
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG |
|---|---|
| Manufacturer group | ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG |
| Product code | QHO |
| Product code name | Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Output Problem, Non Reproducible Results, False Positive Result, False Negative Result, Incorrect Measurement, 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