Device recall
Z-2469-2020: Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-2469-2020 |
|---|---|
| Recall event | 85731 |
| Product | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. |
| Product code | JJE |
| Recalling firm | Siemens Healthcare Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2022 |
| 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