Foundation Medicine, Inc.
3
Recalls
0
Units Recalled
0
Injuries
0
Deaths
Categories: Medical Device
2026-04-29 to 2026-08-26
| Date | Source | Product | Brand | Severity | Units |
|---|---|---|---|---|---|
| 2026-08-26 | FDA Device | FDA Recall: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1C | Foundation Medicine, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOn | Foundation Medicine, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Foundation Medicine, Inc. | Class II | N/A |