Device recall
Z-1891-2010: IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-1891-2010 |
|---|---|
| Recall event | 52206 |
| Product | IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer. |
| Product code | JJE |
| Recalling firm | Siemens Healthcare Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2011 |
| 510(k) numbers | K970227 |
| FEI number | 3005250747 |
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