Recall Z-2951-2026— Foundation Medicine, Inc.

Name: FDA recall Z-2951-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Class II · Ongoing

Class II FDA medical device recall by Foundation Medicine, Inc., initiated 2026-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.. Reason: Software issue that can cause an increase in spontaneous software closures..

Recalling firm: Foundation Medicine, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-06-10
Firm location: Cambridge, MA, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.