FDA Device recall Z-1891-2025
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 an incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1891-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-15 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
FoundationOne Companion Diagnostic (F1CDx)
Reason
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Identifiers
| code_info | Report Number: ORD-XXXXX04-01; 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.