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Open, Classified

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

FDA Recall Z-2951-2026 · Posted 2026-08-14

Recalling FirmFoundation Medicine, Inc.
Recall StatusOpen, Classified
Product CodePQP
Date Initiated2026-06-10
Product Quantity32 units

Reason for Recall

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

Firm Action

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 [email protected].

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of MA & NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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