Device recall
Z-0869-2008: Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0869-2008 |
|---|---|
| Recall event | 47371 |
| Product | Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; Catalog number 03284522001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250 |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 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