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Open, Classified

FoundationOne CDx (F1CDx), RAL-0003 version 31.0

FDA Recall Z-0577-2026 · Posted 2025-11-21

Recalling FirmFoundation Medicine, Inc.
Recall StatusOpen, Classified
Product CodePQP
Date Initiated2022-11-08
Product Quantity59 units (39 US, 20 OUS)

Reason for Recall

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.

Firm Action

On 08 November 2022, Notification Emails with amended reports were emailed to customers. The Foundation Medicine's Medical Affairs team email alerted its customer to a recently issued amended report [Date of Amended Report] for one of your patients [Patient Order Number]. This Amended Report has been issued to update the report template to include the correct [FoundationOneLiquid CDx/FoundationOneCDx] reporting template, including the associated Claims page. Please note that other aspects of this report may have changed from the previous version to reflect the most up-to-date reporting information. If you have questions about this information, please do not hesitate to call 1-888-988-3639 or email: [email protected]. Please confirm receipt of this email or Foundation Medicine can also follow-up with a phone call.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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