Device recall
Z-2591-2018: ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator…
FDA device recall · Class II · ELITech Clinical Systems SAS
Key facts
| Recall number (Z-number) | Z-2591-2018 |
|---|---|
| Recall event | 80321 |
| Product | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 |
| Product code | JIX |
| Recalling firm | ELITech Clinical Systems SAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2020 |
| 510(k) numbers | K945271 |
| 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