{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "220891", "product_res_number": "Z-2899-2026", "event_date_initiated": "2026-05-21", "event_date_posted": "2026-08-06", "recall_status": "Open, Classified", "res_event_number": "99128", "product_code": "CHL", "k_numbers": [ "K223608" ], "product_description": "GEM Premier 7000 with iQM3\n\nPart Numbers: \n\n00077407508\n00077407510\n00077415004\n00077415008\n00077415010\n00077430010\n\nProduct 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_info": "Part No.00077407508\nUDI-DI 00195226000764\nLot 260504E;\n\nPart No. 00077407510\nUDI-DI 00195226000665\nLot 260505B;\n\nPart No. 00077415004\nUDI-DI 00195226000856\nLot 260505A;\n\nPart No. 00077415008\nUDI-DI 00195226000757\nLot No.260505A;\n\nPart No. 00077415010\nUDI-DI 00195226000658\nLot 260505C;\n\nPart No. 00077430010\nUDI-DI 00195226000641\nLot 260505B", "firm_fei_number": "1217183", "recalling_firm": "Instrumentation Laboratory", "address_1": "180 Hartwell Rd", "city": "Bedford", "state": "MA", "postal_code": "01730-2443", "additional_info_contact": "Keith Kelly\n732-3792123", "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.", "root_cause_description": "Nonconforming Material/Component", "action": "On 5/21/26, the firm began notifying consignees in the US via letter. \n\nConsignees were informed that Werfen will be proactively shipping replacement PAKs to each facility. \n\nCustomers were instructed to check inventory for affected product. They should discontinue use of the affected lots and destroy any inventory on hand. Destruction should be documented via the response form provided to the customer and returned to the recalling firm.\n\nCustomers should forward the notification to all affected locations at each facility.\n\nOn May 28, 2026, the field action was expanded to include affected customers in China.\n\nOn June 23, 2026, the field action was expanded to include additional affected lots in Italy and Germany.", "product_quantity": "32 units", "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.", "openfda": { "k_number": [ "K061974", "K974526", "K122729", "K944089", "K936081", "K831015", "K820744", "K953935", "K002738", "K022746", "K832981", "K842519", "K936203", "K994346", "K151978", "K781968", "K123748", "K813517", "K080370", "K223857", "K854608", "K991417", "K942616", "K141907", "K002290", "K914560", "K760748", "K160153", "K963800", "K890827", "K240998", "K955793", "K110416", "K831023", "K881188", "K844781", "K940918", "K961161", "K840843", "K771253", "K945240", "K810308", "K800224", "K133407", "K151856", "K904188", "K131126", "K771147", "K934907", "K151982", "K961657", "K850360", "K200492", "K831024", "K780716", "K200107", "K974396", "K800271", "K833534", "K943882", "K993789", "K792230", "K221900", "K831017", "K093280", "K954711", "K031560", "K853405", "K970710", "K853840", "K882941", "K831025", "K831010", "K833536", "K142898", "K023567", "K946206", "K935830", "K192240", "K992859", "K884267", "K252207", "K831020", "K821483", "K831021", "K914166", "K982928", "K014295", "K963964", "K050423", "K973367", "K904513", "K834601", "K810724", "K823570", "K932642", "K110648", "K961335", "K954612", "K820597", "K852790", "K980991", "K984384", "K000103", "K120197", "K812623", "K891578", "K865036", "K131988", "K943643", "K864445", "K913927", "K954482", "K173797", "K812090", "K230285", "K200986", "K211559", "K831012", "K831016", "K130144", "K823750", "K193246", "K063376", "K244014", "K935069", "K831379", "K142220", "K915087", "K902267", "K770736", "K980523", "K844295", "K043218", "K122642", "K871397", "K980130", "K012478", "K831018", "K935655", "K943570", "K122539", "K992834", "K002613", "K131703", "K800757", "K051804", "K760229", "K922631", "K882209", "K860057", "K772307", "K903965", "K223608", "K884143", "K863880", "K895181", "K962021", "K831019", "K832779", "K982277", "K840300", "K111188", "K111897", "K812552", "K020297", "K924758", "K935121", "K012058", "K100777", "K160412", "K021713", "K990092", "K760969", "K041874", "K203790", "K895317", "K013729", "K831013", "K021515", "K873577", "K924497", "K922922", "K173403", "K841609", "K840468", "K852676", "K771822" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "9610633", "8030478", "3014506106", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "9610126", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ], "fei_number": [ "3002806559", "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "3002806693", "3014506106", "3001576181", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ] } } ] }