{"url_path":"/fda/device/recalls/Z-2951-2026","section_key":"summary","section_title":"DEVICE Recall: Foundation Medicine, Inc. — Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2951-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Foundation Medicine, Inc."},"word_count":111,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2951-2026\n\n**Recalling firm:** Foundation Medicine, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-10\n**Report date:** 2026-08-26\n\n## Product\nHamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.\n\n## Reason\nSoftware issue that can cause an increase in spontaneous software closures.\n\n## Affected lots\nSoftware 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.\n\n## Distribution\nUS Nationwide distribution in the states of MA & NC."}