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Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Recalled December 3, 2025 · FDA recall Z-0577-2026 · Foundation Medicine
Hazard
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. · FDA Class II
Units
59 units (39 US, 20 OUS)
Sold at
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.
Description
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.
Product
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Manufacturer(s)
Foundation Medicine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →