Device recall
Z-0006-2015: ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500…
FDA device recall · Class III · ELITech Clinical Systems SAS
Key facts
| Recall number (Z-number) | Z-0006-2015 |
|---|---|
| Recall event | 69024 |
| Product | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate… |
| Product code | CIT |
| Recalling firm | ELITech Clinical Systems SAS |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2014 |
| 510(k) numbers | K102647 |
| 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