Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2521-2025 — 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 diagno

U.S. FDA — Device Enforcement · United States · 2025-06-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2521-2025
Date of alert: 2025-06-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CARIS LIFE SCIENCES
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00860008613325

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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