Z-1937-2026Class II

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

Name: Z-1937-2026 Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx...
Creator: Foundation Medicine, Inc.
Published: 2026-03-24
License: https://open.fda.gov/license/

Foundation Medicine, Inc. / initiated 2026-03-24 / Open, Classified / root cause: software

FDA source

Foundation Medicine, Inc. began a recall of Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory... on 2026-03-24. FDA classified it as Class II and gives the reason as "Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1937-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-24
Posted: 2026-04-23
Recalling firm: Foundation Medicine, Inc.
Product: 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.
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
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.
Root cause tag: software
FDA root cause: Software change control
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.
Quantity in commerce: 10 units
Distribution: US distribution to North Carolina and Massachusetts.
Product codes and lots: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1937-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-23

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)