ELITech Clinical Systems SAS
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2591-2018 | Class II | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 | April 18, 2017 |
| Z-0217-2016 | Class II | Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glu | September 22, 2015 |
| Z-0214-2016 | Class II | Eon 100 system included the following product reference numbers and names: Reference no. 77345- G | September 22, 2015 |
| Z-0216-2016 | Class II | ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinde | September 22, 2015 |
| Z-0215-2016 | Class II | Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Gl | September 22, 2015 |
| Z-0006-2015 | Class III | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the P | August 11, 2014 |