FDAHealthJune 17, 2025
CARIS LIFE SCIENCES — 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 qualifi
⚠️ Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 17, 2025
U.S. Nationwide distribution in the state of NY.
What's affected?
- 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.
- Brand
- CARIS LIFE SCIENCES
- Lot code
- Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
Additional details
Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1.
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