MI Cancer Seek REF MSC000 UDI Code: — Class II medical device recall Z-2521-2025
Ongoing recall by CARIS LIFE SCIENCES, reported 2025-09-10, distributed nationwide. Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
| Recall number | Z-2521-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CARIS LIFE SCIENCES, Tempe, AZ, United States |
| Recall initiated | 2025-06-17 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00860008613325 |
| Serial numbers | H5HJHDSXF |
| Model numbers | MSC000 |
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 solid malignant neoplasms.
Reason for recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2521-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.