Recall Z-0578-2026 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
| Date | Nov 21, 2025 (initiated Nov 8, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 infor |
| Quantity | 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, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.