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MI Cancer Seek®

CARIS MPI, INC. · Model MCS000 · UDI-DI 00860008613325

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510(k) clearances

Adverse events

Recalls

Facilities

Description

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is 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. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.

Recalls

Date	Firm	Reason
2026-06-10	Foundation Medicine, Inc.	Software issue that can cause an increase in spontaneous software closures.
2026-03-24	Foundation Medicine, Inc.	Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
2026-03-20	Foundation Medicine, Inc.	Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
2025-06-17	CARIS LIFE SCIENCES	Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
2025-04-09	Foundation Medicine, Inc.	Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3)
2024-06-18	Foundation Medicine, Inc.	Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of
2023-02-17	AGILENT TECHNOLOGIES INC./US	Distributed sample collection kit with an unapproved instruction for use.
2023-02-15	Foundation Medicine, Inc.	An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report
2022-11-08	Foundation Medicine, Inc.	Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
2022-11-08	Foundation Medicine, Inc.	Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.