Foundation Medicine, Inc. 2025-12-03 Health serious FDA
Health · FDA · Recall #FDA-Z-0577-2026
FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Recall
Issued December 3, 2025 · Foundation Medicine, Inc.
In December 2025, Foundation Medicine, Inc. recalled the FoundationOne CDx (F1CDx), RAL-0003 version 31.0, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using FoundationOne CDx (F1CDx), RAL-0003 version 31.0 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Foundation Medicine, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Foundation Medicine, Inc.
- Category
- Health
- Recall date
- December 3, 2025
- Units affected
- Not reported
- 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,
- Recall number
- FDA-Z-0577-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Foundation Medicine, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.