Device recall
Z-2922-2018: is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay…
FDA device recall · Class III · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-2922-2018 |
|---|---|
| Recall event | 80684 |
| Product | is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels… |
| Product code | LKJ |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K912291 |
| 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