Device 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.
Z-1937-2026
Product summary
- Event
- Event 98640
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-1937-2026
Official wording
Reason: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Code information: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx)
Distribution pattern: US distribution to North Carolina and Massachusetts.
Derived failure modes
-
Unknown
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.