Z-2521-2025 Class II Ongoing
FDA device recall Z-2521-2025 was initiated by CARIS LIFE SCIENCES on June 17, 2025 and is designated Class II. Reason for recall: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- June 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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
Distribution Pattern
U.S. Nationwide distribution in the state of NY.
Code Information
Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF