Device recall
Z-1712-2017: ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays…
FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1712-2017 |
|---|---|
| Recall event | 76695 |
| Product | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c |
| Product code | JIS |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 9, 2018 |
| 510(k) numbers | K103836 |
| 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