# FDA recall Z-1891-2025

> **Foundation Medicine, Inc.** · Class II · device recall initiated 2023-02-15.

## Product

FoundationOne Companion Diagnostic (F1CDx)

## Reason for recall

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.

## Distribution

US Nationwide distribution in the state of WI.

## Key facts

- **Recall number:** Z-1891-2025
- **Recalling firm:** Foundation Medicine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-15
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2025

## Citation

> AI Analytics. FDA recall Z-1891-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1891-2025. Source: US FDA. Licensed CC0.

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