Recall Z-2521-2025— CARIS LIFE SCIENCES
Class II · Ongoing
Class II FDA medical device recall by CARIS LIFE SCIENCES, initiated 2025-06-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation.
- Recalling firm
- CARIS LIFE SCIENCES
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-17
- Firm location
- Tempe, AZ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.