Device recall
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Recall number
- Z-2951-2026
- Event id
- 99268
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Foundation Medicine, Inc.
- Report date
- Aug 26, 2026
- Initiated
- Jun 10, 2026
- Center classification date
- Aug 14, 2026
- Reason
- Software issue that can cause an increase in spontaneous software closures.
- Quantity
- 32 units
- 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.
- Distribution
- US Nationwide distribution in the states of MA & NC.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Cambridge, MA, United States