Device recall
Z-0697-2016: EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended…
FDA device recall · Class II · Phadia Ab
Key facts
| Recall number (Z-number) | Z-0697-2016 |
|---|---|
| Recall event | 72969 |
| Product | EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other… |
| Product code | LKP |
| Recalling firm | Phadia Ab |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2016 |
| 510(k) numbers | K132631 |
| FEI number | 3002807876 |
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