FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reported: December 3, 2025 Initiated: November 8, 2022 #Z-0577-2026
Product Description
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
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.
Details
- Recalling Firm
- Foundation Medicine, Inc.
- Units Affected
- 59 units (39 US, 20 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
FoundationOne CDx (F1CDx), RAL-0003 version 31.0. Recalled by Foundation Medicine, Inc.. Units affected: 59 units (39 US, 20 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Moderate. Recall number: Z-0577-2026.
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