Facility

FOUNDATION MEDICINE, INC.

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

5inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010679023
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	150 Second St Cambridge, MA, US 02141
Registration status	Active · expires 2026
Parent company	Foundation Medicine, Inc. (owner-operator 10053707)
Brand names	FoundationOne® Liquid CDx

Activity by year

Recalls (9)
Inspections (5)

Devices registered here (1)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Product code PQP (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-06-10
Software issue that can cause an increase in spontaneous software closures.
Class IIOngoing2026-03-24
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Class IIOngoing2026-03-20
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Class IIOngoing2025-04-09
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Class IIOngoing2024-06-18
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Class IIOngoing2023-02-15
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Class IIOngoing2022-11-08
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Class IITerminated2019-08-08
Identified potential false positive MSI-H on the test reports provided to the physicians.
Class IITerminated2018-10-31
An incorrect test result for a single analyte may have been reported for up to 800 physician reports

FDA inspections (5)

NAI2022-07-14
No Action Indicated · Bioresearch Monitoring
NAI2018-07-17
No Action Indicated · Bioresearch Monitoring
VAI2018-02-28
Voluntary Action Indicated · Compliance: Devices; Project Evaluation: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-09-23
Voluntary Action Indicated · Compliance: Devices
VAI2016-08-22
Voluntary Action Indicated · Bioresearch Monitoring; Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FOUNDATION MEDICINE, INC. (FEI 3010679023) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010679023-foundation-medicine-inc/

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