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CARIS LIFE SCIENCES recalls MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t
Recalled September 10, 2025 · FDA recall Z-2521-2025 · CARIS LIFE SCIENCES
Hazard
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation · FDA Class II
Units
1
Sold at
U.S. Nationwide distribution in the state of NY.
Description
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
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.
Manufacturer(s)
CARIS LIFE SCIENCES
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →