CARIS LIFE SCIENCES: Medical Device Recall in 2025 - (Recall #: Z-2521-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 17, 2025

Date Posted: September 10, 2025

Recall Number: Z-2521-2025

Event ID: 97258

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1

Code Information:

Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated