FDA recall Z-1891-2025

Foundation Medicine, Inc. · Class II · device

Product

FoundationOne Companion Diagnostic (F1CDx)

Reason for recall

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.

Distribution

US Nationwide distribution in the state of WI.

Key facts

Status: Ongoing
Initiation date: 2023-02-15
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2025