fda_recall · device_recall · high

Foundation Medicine, Inc. — Class II recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used…

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:52:56Z
Source ID
Z-1937-2026
Payload hash
d3f9130b7b8bc192d382f815

Summary

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

Informational only. Not legal, financial, or medical advice.