Device recall
Z-1435-04: Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR…
FDA device recall · Class III · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-1435-04 |
|---|---|
| Recall event | 29893 |
| Product | Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216). |
| Product code | CIT |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2004 |
| FEI number | 1823260 |
At a glance
- None 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