FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

FDA device recall Z-0578-2026 · posted 2025-11-21 · Open, Classified

Recall details

Recalling firm

Foundation Medicine, Inc.

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.

Action taken

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: client.services@foundationmedicine.com. Please confirm receipt of this email or Foundation Medicine can also follow-up with a phone call.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PQP

Quantity affected

18 units (17 US, 1 OUS)

Distribution

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, Sing

Date initiated

2022-11-08

Date posted

2025-11-21

Location

Cambridge, MA