Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler

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

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

An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 6/10/26 was emailed to consignees. Consignees were instructed to review the impacted equipment list and verify that the PCT V2.0.1 software version has been installed. If software hasn't been updated FMI will follow up to assist with installation. The recall notice is to be forwarded to anyone in the facility or outside the organization that needs to be informed. The notification is to be retained with laboratory records. Questions can be directed to Foundation Medicine at 888-988-3639 or QACTAdverseEventReporting@foundationmedicine.com.

• FDA enforcement recordOfficial FDA database entry for Z-2951-2026
• FDA device classification · PQPOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Foundation Medicine, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.