# FDA recall Z-1937-2026

> **Foundation Medicine, Inc.** · Class II · device recall initiated 2026-03-24.

## Product

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

## Reason for recall

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.

## Distribution

US distribution to North Carolina and Massachusetts.

## Key facts

- **Recall number:** Z-1937-2026
- **Recalling firm:** Foundation Medicine, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-24
- **Report date:** 2026-04-29

- **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-1937-2026

## Citation

> AI Analytics. FDA recall Z-1937-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-1937-2026. Source: US FDA. Licensed CC0.

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