Device recall
Z-0178-2014: Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium…
FDA device recall · Class II · SEPPIM SAS
Key facts
| Recall number (Z-number) | Z-0178-2014 |
|---|---|
| Recall event | 66331 |
| Product | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic… |
| Product code | CJY |
| Recalling firm | SEPPIM SAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2013 |
| 510(k) numbers | K110830 |
| FEI number | 3007662974 |
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