Device recall
Z-0214-2016: Eon 100 system included the following product reference numbers and names…
FDA device recall · Class II · ELITech Clinical Systems SAS
Key facts
| Recall number (Z-number) | Z-0214-2016 |
|---|---|
| Recall event | 72322 |
| Product | Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310… |
| 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