MAUDE manufacturer profile
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. · JKA
MAUDE profile for Tubes, Vials, Systems, Serum Separators, Blood Collection
Key facts
| Manufacturer | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
|---|---|
| Manufacturer group | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Product code | JKA |
| Product code name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Short Fill, Incorrect, Inadequate or Imprecise Result or Readings, Device Contamination with Chemical or Other Material, No Known Impact Or Consequence To Patient, Material Deformation, Device Ingredient or Reagent Problem, Volume Accuracy Problem 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