Device recall
Z-2627-2017: DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R)…
FDA device recall · Class III · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-2627-2017 |
|---|---|
| Recall event | 77426 |
| Product | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) 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 (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA… |
| Product code | LKJ |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 31, 2021 |
| 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