FDA Device recall Z-2951-2026
Hamilton Microlab STAR Liquid Handler
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Hamilton Microlab STAR Liquid Handler by Foundation Medicine, citing software issue that can cause an increase in spontaneous software closures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2951-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-10 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
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.
Identifiers
| code_info | Software Version: Protocol Configuration Tool (PCT) v2.0.0; Equipment ID: 100071, 100213, 100355, 102281, 103047, 10415…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2951-2026%22
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