{"recall":{"id":"fda-device-99268","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler","firm":"Foundation Medicine, Inc.","date":"2026-06-10","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.","code":"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.","quantity":"32 units","number":"Z-2951-2026","classification":"Class II"}],"reason":"Software issue that can cause an increase in spontaneous software closures.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of MA & NC.","nationwide":true,"states":[],"units":"32 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99268","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5f079ff443a2c71d","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99268","record":[{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99268","recalling_firm":"Foundation Medicine, Inc.","address_1":"150 2nd St","address_2":"","postal_code":"02141-2115","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of MA & NC.","recall_number":"Z-2951-2026","product_description":"Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.","product_quantity":"32 units","reason_for_recall":"Software issue that can cause an increase in spontaneous software closures.","recall_initiation_date":"20260610","center_classification_date":"20260814","report_date":"20260826","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.","more_code_info":""}]}}