Device recall
Z-2919-2018: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the…
FDA device recall · Class III · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-2919-2018 |
|---|---|
| Recall event | 80684 |
| Product | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly… |
| Product code | LKO |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K905194 |
| FEI number | 3007610287 |
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