Device recall
Z-1345-2022: CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the…
FDA device recall · Class II · Menarini Silicon Biosystems
Key facts
| Recall number (Z-number) | Z-1345-2022 |
|---|---|
| Recall event | 90417 |
| Product | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001 |
| Product code | NQI |
| Recalling firm | Menarini Silicon Biosystems |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K103502 |
| FEI number | 3004153557 |
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