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.
Reported: September 10, 2025 Initiated: June 17, 2025 #Z-2521-2025
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.
Reason for Recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Details
- Recalling Firm
- CARIS LIFE SCIENCES
- Units Affected
- 1
- Distribution
- U.S. Nationwide distribution in the state of NY.
- Location
- Tempe, AZ
Frequently Asked Questions
What product 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.. Recalled by CARIS LIFE SCIENCES. Units affected: 1.
Why was this product recalled? ▼
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2521-2025.
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