- 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.
- Affected products (lot / model / serial)
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
- Units affected
- 10 units
- Distribution pattern
- US distribution to North Carolina and Massachusetts.
- Firm location
- Cambridge, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1937-2026
- Recall initiated
- March 24, 2026
- FDA classification date
- April 23, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98640
- Last updated on HTM Vibe
- July 24, 2026