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.

Recall Insight

This FDA Devices action (record #Z-2521-2025) was formally reported on September 10, 2025, with the manufacturer initiating the action on June 17, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. CARIS LIFE SCIENCES is listed as the recalling firm, operating out of Tempe, AZ. Federal records indicate 1 units are affected.

The documented reason for this recall is: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the state of NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.