# FDA recall Z-1747-2025

> **Foundation Medicine, Inc.** · Class II · device recall initiated 2025-04-09.

## Product

FoundationOne Companion Diagnostic (F1CDx)

## Reason for recall

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) with tumor profiling result changes did not impact CDx indications.

## Distribution

Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.

## Key facts

- **Recall number:** Z-1747-2025
- **Recalling firm:** Foundation Medicine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-09
- **Report date:** 2025-05-21

- **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-1747-2025

## Citation

> AI Analytics. FDA recall Z-1747-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1747-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*