Device recall
Z-1216-2017: The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1216-2017 |
|---|---|
| Recall event | 76293 |
| Product | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only. |
| Product code | JIX |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 2, 2018 |
| 510(k) numbers | K103612 |
| FEI number | 2517506 |
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