Device recall
Z-2014-2021: The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN)…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2014-2021 |
|---|---|
| Recall event | 88086 |
| Product | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic… |
| Product code | JGS |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 30, 2024 |
| 510(k) numbers | K990346 |
| FEI number | 2432235 |
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