FDA Device recall Z-1747-2025
FoundationOne Companion Diagnostic (F1CDx)
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of FoundationOne Companion Diagnostic (F1CDx) by Foundation Medicine, citing four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1747-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-09 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
FoundationOne Companion Diagnostic (F1CDx)
Reason
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Identifiers
| code_info | ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 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-1747-2025%22
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