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Foundation Medicine, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.Class IIJun 10, 2026Software issue that can cause an increase in spontaneous sof |
| Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installClass IIMar 24, 2026Potential for spontaneous closures of Hamilton HxRunControl |
| Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)Class IIMar 20, 2026Possible increase in phasing, potentially resulting in false |
| FoundationOne Companion Diagnostic (F1CDx)Class IIApr 9, 2025Four (4) total reports were sent to customers with clinicall |
| FoundationOne Companion Diagnostic (F1CDx)Class IIJun 18, 2024Two (2) reports were sent to customers with an incorrect neg |
| FoundationOne Companion Diagnostic (F1CDx)Class IIFeb 15, 2023An incorrect negative claim was identified on the claims pag |
| FoundationOne CDx (F1CDx), RAL-0003 version 31.0Class IINov 8, 2022Reports were sent to customers without the companion diagnos |
| FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0Class IINov 8, 2022Reports were sent to customers without the companion diagnos |