Device recall
Z-0306-2018: Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA…
FDA device recall · Class II · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-0306-2018 |
|---|---|
| Recall event | 77107 |
| Product | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process. |
| Product code | LKJ |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2018 |
| 510(k) numbers | K932876 |
| FEI number | 3007610287 |
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