FDA recall Z-2951-2026

Foundation Medicine, Inc. · Class II · device

Product

Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

Reason for recall

Software issue that can cause an increase in spontaneous software closures.

Distribution

US Nationwide distribution in the states of MA & NC.

Key facts

Status
Ongoing
Initiation date
2026-06-10
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2951-2026