# FDA recall Z-0577-2026

> **Foundation Medicine, Inc.** · Class II · device recall initiated 2022-11-08.

## Product

FoundationOne CDx (F1CDx), RAL-0003 version 31.0

## Reason for recall

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.

## Distribution

US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV.  OUS International to countries: Japan, Singapore.

## Key facts

- **Recall number:** Z-0577-2026
- **Recalling firm:** Foundation Medicine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-08
- **Report date:** 2025-12-03

- **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-0577-2026

## Citation

> AI Analytics. FDA recall Z-0577-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0577-2026. Source: US FDA. Licensed CC0.

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