MAUDE manufacturer profile
BAYER HEALTHCARE LLC · JJX
MAUDE profile for Single (Specified) Analyte Controls (Assayed And Unassayed)
Key facts
| Manufacturer | BAYER HEALTHCARE LLC |
|---|---|
| Manufacturer group | BAYER HEALTHCARE LLC |
| Product code | JJX |
| Product code name | Single (Specified) Analyte Controls (Assayed And Unassayed) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Or Inadequate Test Results, Device Operates Differently Than Expected, Display or Visual Feedback Problem, No Consequences Or Impact To Patient, High Test Results, Improper or Incorrect Procedure or Method 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