Device recall
Z-2918-2018: Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for…
FDA device recall · Class II · Euro Diagnostica AB
Key facts
| Recall number (Z-number) | Z-2918-2018 |
|---|---|
| Recall event | 80689 |
| Product | Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. |
| Product code | NHX |
| Recalling firm | Euro Diagnostica AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K091657 |
| 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