Company: Foundation Medicine, Inc.
Date of Enforcement Report: 8/14/2026
Class: II

PRODUCT

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Recall Number:

Z-2951-2026

REASON:

Software issue that can cause an increase in spontaneous software closures.

RECALLING FIRM/MANUFACTURER:

Foundation Medicine, Inc.

VOLUME:

32 units

DISTRIBUTION:

US Nationwide distribution in the states of MA & NC.