Official recall notice
FDA DeviceClass IINotable
FDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOn
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Recommended action
What to do
10 units
Product description
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.