Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Recalled by CARIS LIFE SCIENCES Due to Due to an incorrect test results provided that...

Date: June 17, 2025
Company: CARIS LIFE SCIENCES
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CARIS LIFE SCIENCES directly.

Affected Products

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.

Quantity: 1

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CARIS LIFE SCIENCES

CARIS LIFE SCIENCES has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report