Device recall
Z-0217-2016: Envoy 500 system includes the following product reference numbers and names…
FDA device recall · Class II · ELITech Clinical Systems SAS
Key facts
| Recall number (Z-number) | Z-0217-2016 |
|---|---|
| Recall event | 72322 |
| Product | Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL… |
| Product code | CGA |
| Recalling firm | ELITech Clinical Systems SAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2016 |
| 510(k) numbers | K100525 |
| FEI number | 3007662974 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database