FoundationOne CDx — Class II medical device recall Z-0577-2026
Ongoing recall by Foundation Medicine, Inc., reported 2025-12-03, distributed nationwide. Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distribut
| Recall number | Z-0577-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2022-11-08 |
| Classified | 2025-11-21 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, SG |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0577-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.