Hamilton Microlab STAR Liquid Handler recall (Foundation Medicine, Inc.)
Medical deviceClass IIOngoing
Summary: Foundation Medicine, Inc. is recalling Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.. Reason: Software issue that can cause an increase in spontaneous software closures.
What is being recalled
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Why
Software issue that can cause an increase in spontaneous software closures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of MA & NC. (states named: Massachusetts, North Carolina)
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2951-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 10, 2026 |
| Reported | August 26, 2026 |
| Company | Foundation Medicine, Inc. |
| Company location | Cambridge, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 32 units |
More recalls from Foundation Medicine, Inc. · all medical device recalls · recalls from June 2026