CARIS LIFE SCIENCES recalls MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to p…

Recall date

June 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2521-2025

FDA classification

Class II

Brand / firm

CARIS LIFE SCIENCES

Sold / distributed

U.S. Nationwide distribution in the state of NY.

Why it was recalled

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.