Foundation Medicine, Inc.: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

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

Tags

FDA recall, medical device, class 3, Unknown, Software change control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-1937-2026

First seen by InfoSec Signals

9/23/2026

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.