# FDA recall Z-2521-2025

> **CARIS LIFE SCIENCES** · Class II · device recall initiated 2025-06-17.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2521-2025
- **Recalling firm:** CARIS LIFE SCIENCES
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-17
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2025

## Citation

> AI Analytics. FDA recall Z-2521-2025. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-2521-2025. Source: US FDA. Licensed CC0.

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