Device recall
Z-1399-2009: Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number…
FDA device recall · Class II · Siemens Medical Solutions Diagnostics
Key facts
| Recall number (Z-number) | Z-1399-2009 |
|---|---|
| Recall event | 50849 |
| Product | Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. |
| Product code | DGC |
| Recalling firm | Siemens Medical Solutions Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2010 |
| 510(k) numbers | K033234 |
| FEI number | 1000122204 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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