FDA Device recall Z-1890-2025
FoundationOne Companion Diagnostic (F1CDx)
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of FoundationOne Companion Diagnostic (F1CDx) by Foundation Medicine, citing two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1890-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-18 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
FoundationOne Companion Diagnostic (F1CDx)
Reason
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Identifiers
| code_info | Report Numbers: ORD-XXXXX77-01, ORD-XXXXX91-01. Note: The above characters have been redacted to minimize patient information disclosure. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Foundation Medicine
- Hamilton Microlab STAR Liquid Handler
FDA Device · Class II · 2026-08-26 · Foundation Medicine - Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Tria…
FDA Device · Class II · 2026-04-29 · Foundation Medicine - Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
FDA Device · Class II · 2026-04-29 · Foundation Medicine - FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine - FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Device · Class II · 2025-12-03 · Foundation Medicine
All Foundation Medicine recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2025%22
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