Device recall
Z-2521-2025: MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer…
FDA device recall · Class II · CARIS LIFE SCIENCES
Key facts
| Recall number (Z-number) | Z-2521-2025 |
|---|---|
| Recall event | 97258 |
| Product | MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed… |
| Product code | PQP |
| Recalling firm | CARIS LIFE SCIENCES |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P240010 |
| FEI number | 3008335090 |
At a glance
- None 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