Hamilton Microlab STAR Liquid Handler — Class II medical device recall Z-2951-2026
Ongoing recall by Foundation Medicine, Inc., reported 2026-08-26, distributed nationwide. Software issue that can cause an increase in spontaneous software closures.
| Recall number | Z-2951-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2026-06-10 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 32 units |
| Reason classes | software |
Product
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Reason for recall
Software issue that can cause an increase in spontaneous software closures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2951-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.