Class IIReported 2025-12-03

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

Recalled by 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.

Recall Number

Z-0578-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2022-11-08

Reported

2025-12-03

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.

Code Info

F1LCDx - TECH-0009 version 6.0; Test Numbers: ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US), ORD-XXXX099-01 (US), ORD-XXXX089-01 (US), ORD-XXXX252-01 (US), ORD-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US),

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.