Device recall
Z-1138-03: Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on…
FDA device recall · Class III · DPC Cirrus
Key facts
| Recall number (Z-number) | Z-1138-03 |
|---|---|
| Recall event | 26892 |
| Product | Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. |
| Product code | JJE |
| Recalling firm | DPC Cirrus |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 1, 2004 |
| FEI number | 1000122204 |
At a glance
- None 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