FDA recall Z-1890-2025

Product

FoundationOne Companion Diagnostic (F1CDx)

Reason for recall

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.

Distribution

US Nationwide distribution in the state of MI.

Key facts

Status

Ongoing

Initiation date

2024-06-18

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-1890-2025