FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1937-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2026-03-24
- Posted
- 2026-04-23
- Terminated
- not on file
- 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 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
- 10 units
- Distribution
- US distribution to North Carolina and Massachusetts.
- Lot, serial or model codes
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
- 510(k) numbers
- not on file
- PMA numbers
- ["P170019"]
- Product code
- PQP
- Firm FEI
- 3010679023
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28