Recall Z-1937-2026 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
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.
| Date | Apr 23, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 i |
| Quantity | 10 units |
| Distribution | US distribution to North Carolina and Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.