Device recall
Z-2000-2009: Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-2000-2009 |
|---|---|
| Recall event | 51896 |
| Product | Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma. |
| Product code | DKB |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2009 |
| 510(k) numbers | K031856 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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