Device recall
Z-0215-2016: Eon 300 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-0215-2016 |
|---|---|
| Recall event | 72322 |
| Product | Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310… |
| 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