FDAJune 17, 2025device

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 diagnos...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

caris life sciencescariscaris life

UPCs

00860008613325

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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