Drug recall
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and…
FDA recall event 99268 · Class II · Foundation Medicine, Inc.
Key facts
| Event ID | 99268 |
|---|---|
| Recall numbers | Z-2951-2026 |
| Recalling firm | Foundation Medicine, Inc. |
| Product type | Devices |
| Products | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software issue that can cause an increase in spontaneous software closures. |
| Initiation date | Jun 10, 2026 |
| Report date | Aug 26, 2026 |
| City | Cambridge |
| State | MA |
| Country | United States |
| FEI number | 3010679023 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: