FDA DevicesClass II
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used...
Published: April 29, 2026Recall ID: Z-1937-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98640 |
| Address 1 | 150 2nd St |
| Address 2 | N/A |
| Code info | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) |
| Postal code | 02141-2115 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 10 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | |
| Center classification date | 20260423 |
Overview
- Recalling FirmFoundation Medicine, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution to North Carolina and Massachusetts.