Brand
Foundation Medicine
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Foundation Medicine and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-03FDA-DeviceClass IIFoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
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.
- 2025-12-03FDA-DeviceClass IIFoundationOne CDx (F1CDx), RAL-0003 version 31.0
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.
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