FDA recall record · openFDA

Foundation Medicine, Inc.

5 FDA recalls on record (2023–2026) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which wi 1

Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deploym 1

An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in 1

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants 1

Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant informati 1

Recalls

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install Class II 2026-03-24 Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Class II 2026-03-20 FoundationOne Companion Diagnostic (F1CDx) Class II 2025-04-09 FoundationOne Companion Diagnostic (F1CDx) Class II 2024-06-18 FoundationOne Companion Diagnostic (F1CDx) Class II 2023-02-15

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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