PlainRecalls

Foundation Medicine, Inc.

Compiled from official public sources by the publisher.

9 recalls on record · Latest: Apr 29, 2026

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Agency notice ledger

Federal filing book Foundation Medicine, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,596 of 14,151 · 9 notices · 0.009% archive

  • BOOK 9 notices
  • RANK #1,596 of 14,151
  • SHARE 0.009% archive
  • AGENCY FDA Devices (9)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 29, 2026
  • PHOTO 3Cs Organics LLC

Nearest notice-volume peer: 3Cs Organics LLC (0 notice gap)

Foundation Medicine, Inc. accounts for about 0.009% of the 104,423-notice archive on 9 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Foundation Medicine, Inc. sits among 14,151 recalling firms

Foundation Medicine, Inc. ranks 1,596th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Foundation Medicine, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

9 1596th of 14151 higher than 12,464 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Foundation Medicine, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Foundation Medicine, Inc. holds about 0.009% of archive notices alongside 9 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 29, 2026

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
FDA Devices Moderate Apr 29, 2026

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Devices Moderate Dec 3, 2025

FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Devices Moderate Dec 3, 2025

FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Devices Moderate Jun 11, 2025

FoundationOne Companion Diagnostic (F1CDx)
FDA Devices Moderate Jun 11, 2025

FoundationOne Companion Diagnostic (F1CDx)
FDA Devices Moderate May 21, 2025

FoundationOne Companion Diagnostic (F1CDx)
FDA Devices Moderate Dec 4, 2019

FoundationOne CDx test report
FDA Devices Moderate Dec 26, 2018

FoundationOne CDx Test Results

Foundation Medicine, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Abbott Medical Optics, Inc. 9 Arjo, Inc. dba ArjoHuntleigh 9 B-k Medical A/s 9 Baxter Corporation Englewood 9

Frequently Asked Questions

How many federal recall notices name Foundation Medicine, Inc.? ▼
PlainRecalls indexes 9 distinct federal recall events naming Foundation Medicine, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Foundation Medicine, Inc. sit among other recalling firms? ▼
Foundation Medicine, Inc. ranks #1,596 of 14,151 by distinct recall-event count among 14,151 firms in this archive (88th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Foundation Medicine, Inc.'s notices? ▼
FDA Devices accounts for 9 of this firm's 9 indexed notices.
What product category dominates Foundation Medicine, Inc.'s filing book? ▼
Filings for Foundation Medicine, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Foundation Medicine, Inc.: 9 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Foundation Medicine, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026