Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)

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.

FoundationOne Companion Diagnostic (F1CDx)

On April 9, 2025 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers. Asked Customer Immediate Actions: Foundation Medicine respectfully requests your support with the following actions: 1. Review, complete, sign and return the attached business reply form to be returned in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 2. Forward this notice to anyone in your facility that needs to be informed. 3. If there is any impact that requires this notice to be forwarded to another facility, contact that facility and provide them with this letter. 4. Keep a copy of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Foundation Medicine apologizes for any inconvenience caused by this issue. If any further information or support concerning this issue is needed, please contact Foundation Medicine at any time.

• FDA enforcement recordOfficial FDA database entry for Z-1747-2025
• FDA device classification · PQPOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Foundation Medicine, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.