{"recall":{"id":"fda-device-99128","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Instrumentation Laboratory recalls 2 products","firm":"Instrumentation Laboratory","date":"2026-05-21","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.","code":"Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B","quantity":"32 units","number":"Z-2899-2026","classification":"Class II"},{"name":"GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A","code":"Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;","quantity":"109 units","number":"Z-2900-2026","classification":"Class II"}],"reason":"The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae. The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.","nationwide":true,"states":[],"units":"32 units; 109 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=99128","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"56e47a6de9708d1a","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=99128","record":[{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99128","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.","recall_number":"Z-2899-2026","product_description":"GEM Premier 7000 with iQM3    Part Numbers:     00077407508  00077407510  00077415004  00077415008  00077415010  00077430010    Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.","product_quantity":"32 units","reason_for_recall":"The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.","recall_initiation_date":"20260521","center_classification_date":"20260806","report_date":"20260812","code_info":"Part No.00077407508 UDI-DI 00195226000764 Lot 260504E;  Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B;  Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A;  Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A;  Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C;  Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B","more_code_info":""},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99128","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.","recall_number":"Z-2900-2026","product_description":"GEM Premier 5000 PAK    Part Numbers:     00055360010  00055360011  00055407504  00055415010  00055430010  00055430011  00055445010  00055445011  00055360010.A","product_quantity":"109 units","reason_for_recall":"The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.","recall_initiation_date":"20260521","center_classification_date":"20260806","report_date":"20260812","code_info":"Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F;  Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J;  Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R;  Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K;  Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F;  Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K;  Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K;  Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J;  Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;","more_code_info":""}]}}