Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
FDA Recall Z-1937-2026 · Posted 2026-04-23
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Recalling FirmFoundation Medicine, Inc.
Recall StatusOpen, Classified
Product CodePQP
Date Initiated2026-03-24
Product Quantity10 units
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.
Firm Action
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
Distribution Pattern
US distribution to North Carolina and Massachusetts.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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