Device recall
Z-1068-2009: Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1068-2009 |
|---|---|
| Recall event | 50171 |
| Product | Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The… |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2009 |
| 510(k) numbers | K953239 |
| FEI number | 1823260 |
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