Device recall
Z-0073-2007: HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc…
FDA device recall · Class III · Sebia, Inc.
Key facts
| Recall number (Z-number) | Z-0073-2007 |
|---|---|
| Recall event | 36413 |
| Product | HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France |
| Product code | JBD |
| Recalling firm | Sebia, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 28, 2010 |
| 510(k) numbers | K963853 |
| FEI number | 3001595416 |
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