Foundation Medicine, Inc.: Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Foundation Medicine, Inc.
- Product
- Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
- Reason / hazard
- Software issue that can cause an increase in spontaneous software closures.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of MA & NC.
- Recall initiated
- 2026-06-10
- 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.
- Product quantity
- 32 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 99268
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