Device 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.
Z-2521-2025
Product summary
- Event
- Event 97258
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2521-2025
Official wording
Reason: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Code information: Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
Distribution pattern: U.S. Nationwide distribution in the state of NY.
Derived failure modes
-
Unknown
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation