Medical Device Recall: 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 professi
CARIS LIFE SCIENCES · June 17, 2025
Reason for Recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Product Description
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.
Distribution
U.S. Nationwide distribution in the state of NY.
States Affected
NATIONWIDE
Quantity Affected
1
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2521-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.