Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install

FDA device recall Z-1937-2026 · posted 2026-04-23 · Open, Classified

Recall details

Recalling firm

Foundation Medicine, Inc.

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.

Action taken

Foundation Medicine, Inc. (FMI) notified consignees of the recall on 03/24/2026 via emailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter. Consignees were instructed to complete and return the provided business reply form, review impacted equipment and verify that the PCT V1.3.1 version of the software has been installed, and if the PCT V1.3.1 has not been installed upon the equipment listed above, to indicate as such on the business reply form below. FMI will follow up to assist with installation. Consignees were also instructed to forward the notification to applicable personnel and if there is any impact that requires the notice to be forwarded to another facility, contact that facility and provide them with the notification letter.

Root cause

Software change control

Status

Open, Classified

Product code

PQP

Quantity affected

10 units

Distribution

US distribution to North Carolina and Massachusetts.

Date initiated

2026-03-24

Date posted

2026-04-23

Location

Cambridge, MA