Device recall
Z-0972-2010: Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0972-2010 |
|---|---|
| Recall event | 53546 |
| Product | Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. |
| Product code | LCD |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2010 |
| 510(k) numbers | K020704 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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