Device recall
Z-0458-2016: Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-0458-2016 |
|---|---|
| Recall event | 72738 |
| Product | Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS… |
| Product code | JJE |
| Recalling firm | Siemens Healthcare Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2017 |
| 510(k) numbers | K130276 |
| FEI number | 3002755490 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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