FDA recall Z-1747-2025

Product

FoundationOne Companion Diagnostic (F1CDx)

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.

Key facts

Status

Ongoing

Initiation date

2025-04-09

Report date

2025-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1747-2025