Device recall
Z-0929-2018: DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number…
FDA device recall · Class II · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-0929-2018 |
|---|---|
| Recall event | 79183 |
| Product | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro… |
| Product code | LKJ |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2019 |
| 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