Device recall
Z-0028-04: Roche/Hitachi brand lactate reagent for the quantitative determination of…
FDA device recall · Class II · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0028-04 |
|---|---|
| Recall event | 27164 |
| Product | Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837. |
| Product code | LNN |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2003 |
| FEI number | 1823260 |
At a glance
- None 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