Class IIDeviceOngoing

Foundation Medicine, Inc.

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.

Details

Recall number: Z-2951-2026
Event ID: 99268
Recall initiated: Jun 10, 2026
Classified: Aug 14, 2026
Reported: Aug 26, 2026
Quantity: 32 units
Distribution: US Nationwide distribution in the states of MA & NC.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Cambridge, MA, United States
Lot / code info: Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 104154, 104201, 104202, 104204, 104205, 104224, 104503, 104504, 104562, 104885, 105961, 106497, 00016, 00487, 00488, 00489, 00490, 00817, 00491, 00492, 00854, 01173, 01174, 01785, 01337, 01596, 01993.