Device recall
Z-0994-05: IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro…
FDA device recall · Class III · DPC Cirrus
Key facts
| Recall number (Z-number) | Z-0994-05 |
|---|---|
| Recall event | 32010 |
| Product | IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836 |
| Product code | JJE |
| Recalling firm | DPC Cirrus |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 29, 2006 |
| 510(k) numbers | K970227 |
| FEI number | 1000122204 |
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