Z-2951-2026 Class II Ongoing
FDA device recall Z-2951-2026 was initiated by Foundation Medicine, Inc. on June 10, 2026 and is designated Class II. Reason for recall: Software issue that can cause an increase in spontaneous software closures. The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- June 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of MA & NC.
Code Information
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.