MAUDE manufacturer profile
ROCHE DIAGNOSTICS · LCP
MAUDE profile for Assay, Glycosylated Hemoglobin
Key facts
| Manufacturer | ROCHE DIAGNOSTICS |
|---|---|
| Manufacturer group | HITACHI HIGH TECH CORP. |
| Product code | LCP |
| Product code name | Assay, Glycosylated Hemoglobin |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- High Test Results, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Low Test Results, Non Reproducible Results, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Or Inadequate Test Results 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