FoundationOne CDx (F1CDx), RAL-0003 version 31.0
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 08, 2022 |
| Reported | December 03, 2025 |
| Recalling firm | Foundation Medicine, Inc. |
| Country / region | United States MA |
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.
Affected products
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Related recalls
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