FDA-Device2025-09-10Class II
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.
CARIS LIFE SCIENCES
Hazard
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Sold states
U.S. Nationwide distribution in the state of NY.
Affected count
1
Manufactured in
350 W Washington St Fl 4, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2025Don't want to check this manually?
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