{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220854", "product_res_number": "Z-2821-2026", "event_date_initiated": "2026-05-08", "event_date_posted": "2026-07-29", "recall_status": "Open, Classified", "res_event_number": "99115", "product_code": "CHL", "k_numbers": [ "K203790" ], "product_description": "GEM Premier 5000 with IQM2 \nModel/Catalog Number: 00024019255 and \nGEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 \n\nPortable blood analyzer system. \n\nAffected Accessory: \nBar Code Reader (BCR) Wand Part No. 00024015859", "code_info": "GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227 \nGEM Premier 7000 Part number: 00000015279, UDI: 0195226000924 \n\nAffected Accessory:\nBar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.\nPart No. 00024015859; UDI No. 08426950869634", "firm_fei_number": "1217183", "recalling_firm": "Instrumentation Laboratory", "address_1": "180 Hartwell Rd", "city": "Bedford", "state": "MA", "postal_code": "01730-2443", "additional_info_contact": "781-861-4467", "reason_for_recall": "Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.", "root_cause_description": "Software Design Change", "action": "Werfen dba Instrumentation laboratory notified consignees on about 05/08/2026 via letter and/or email. Consignees were instructed to discontinue use of the affected BCR wands immediately, manually enter patient IDs when performing testing on the GEM Premier 5000 and/or 7000 until the BCR wands have been replaced, contact Werfen Service at 1-800-955-9525 to arrange for prompt replacement of the affected BCR wands, post this notification on or near affected GEM Premier 5000 and/or 7000 instruments, and inform all laboratory staff of this notification. Consignees were also instructed to forward the notification to all affected locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form within 10 days of receipt. \n\nIn addition to the tracked customer notification, a Service Information (SI) 2026-09 was issued on May 11, 2026, for service personnel to track the destruction of the affected BCR wands. The Service Information includes a destruction form for service personnel to document the destruction of the affected BCR wands and to return the form to Regulatory for tracking purposes.", "product_quantity": "122", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K860057", "K904513", "K831015", "K014295", "K111897", "K173403", "K974396", "K800757", "K974526", "K122539", "K992834", "K812090", "K223857", "K133407", "K820744", "K770736", "K760969", "K954711", "K946206", "K991417", "K051804", "K100777", "K021713", "K934907", "K151978", "K110416", "K935121", "K913927", "K831020", "K221900", "K852676", "K020297", "K945240", "K061974", "K151982", "K914560", "K884143", "K871397", "K203790", "K013729", "K000103", "K832779", "K831010", "K943570", "K982928", "K200107", "K780716", "K833536", "K831023", "K842519", "K853840", "K131988", "K211559", "K943643", "K772307", "K041874", "K993789", "K760229", "K821483", "K924497", "K160412", "K903965", "K031560", "K012058", "K980991", "K813517", "K970710", "K831017", "K953935", "K963964", "K984384", "K023567", "K831019", "K831013", "K160153", "K230285", "K123748", "K192240", "K151856", "K961335", "K831024", "K902267", "K223608", "K962021", "K924758", "K891578", "K771822", "K990092", "K122729", "K810308", "K834601", "K800224", "K831018", "K120197", "K021515", "K915087", "K831016", "K890827", "K940918", "K173797", "K823750", "K800271", "K992859", "K832981", "K942616", "K961657", "K831021", "K864445", "K812623", "K884267", "K935830", "K833534", "K252207", "K844781", "K122642", "K922922", "K840300", "K771147", "K980523", "K932642", "K831012", "K812552", "K881188", "K882209", "K936081", "K193246", "K200986", "K994346", "K002613", "K823570", "K853405", "K935655", "K873577", "K954482", "K922631", "K973367", "K142220", "K760748", "K850360", "K131126", "K935069", "K111188", "K831025", "K944089", "K914166", "K012478", "K954612", "K961161", "K980130", "K865036", "K963800", "K080370", "K982277", "K771253", "K844295", "K244014", "K781968", "K852790", "K831379", "K142898", "K863880", "K131703", "K943882", "K130144", "K050423", "K904188", "K002290", "K200492", "K936203", "K895181", "K043218", "K840843", "K810724", "K022746", "K002738", "K792230", "K063376", "K240998", "K895317", "K141907", "K955793", "K840468", "K854608", "K882941", "K093280", "K841609", "K110648", "K820597" ], "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": [ "1219029", "3015997711", "3003971136", "3004102403", "2050012", "3007490412", "3012104670", "3006198300", "3003795116", "1036362", "1217183", "1717966", "3012817228", "9610126", "8030478", "3002807968", "1222035", "2432235", "2245578", "3013513377", "3005643513", "3002637618", "1220649", "3007662974", "1219913", "3037000637", "9610633", "3023162659", "1220972", "1181121", "2431530", "1000455123", "3014506106", "3004959793" ], "fei_number": [ "1219029", "3002806693", "3015997711", "3003971136", "3002806559", "3004102403", "2050012", "3007490412", "3012104670", "3006198300", "3003795116", "1036362", "1217183", "1717966", "3012817228", "3002807968", "1222035", "2432235", "3001576181", "2245578", "3013513377", "3005643513", "3002637618", "1220649", "3007662974", "1219913", "3037000637", "3023162659", "1220972", "1181121", "2431530", "1000455123", "3014506106", "3004959793" ] } } ] }