FDA-Device2025-12-03Class IIMISBRANDING
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
59 units (39 US, 20 OUS)
Manufactured in
150 2nd St, N/A, Cambridge, MA, United States
Products
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0577-2026Want us to check the next one for you?
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