Foundation Medicine, Inc. — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-04-29, Argus HQ recorded a FDA recall for Foundation Medicine, Inc., rated "high" severity in Argus HQ's classification: Foundation Medicine, Inc. — Class II recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Foundation Medicine, Inc., rated "high" severity in Argus HQ's classification: Foundation Medicine, Inc. — Class II recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Foundation Medicine, Inc. has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Foundation Medicine, Inc. has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Frequently asked questions

Is this FDA enforcement data for Foundation Medicine, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Foundation Medicine, Inc. had?

Argus HQ has recorded 2 FDA events for Foundation Medicine, Inc.: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Foundation Medicine, Inc.?

The most recent FDA event Argus HQ has on file for Foundation Medicine, Inc. is dated 2026-04-29, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Foundation Medicine, Inc. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Foundation Medicine, Inc. is observed, this page's event count and history update automatically.

Related enforcement actions

• Foundation Medicine, Inc. — Class II recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used… →
• Foundation Medicine, Inc. — Class II recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) →

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