Device recall
Z-0003-2007: Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
FDA device recall · Class III · Axis-Shield Diagnostics, Ltd.
Key facts
| Recall number (Z-number) | Z-0003-2007 |
|---|---|
| Recall event | 36018 |
| Product | Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) |
| Product code | NHX |
| Recalling firm | Axis-Shield Diagnostics, Ltd. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 3, 2007 |
| 510(k) numbers | K021516, K023285 |
| FEI number | 3002808140 |
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