FDA recall Z-2521-2025

CARIS LIFE SCIENCES · Class II · device

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 for recall

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

Distribution

U.S. Nationwide distribution in the state of NY.

Key facts

Status
Ongoing
Initiation date
2025-06-17
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2025