CARIS LIFE SCIENCES: Device Recall
Recall #Z-2521-2025 · 06/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2521-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- CARIS LIFE SCIENCES
- Status
- Ongoing
- Date Initiated
- 06/17/2025
- Location
- Tempe, AZ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Reason for Recall
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
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.
Distribution Pattern
U.S. Nationwide distribution in the state of NY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.