{ "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": 6 } }, "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": "Brand Name: GEM Premier 5000\nProduct Name: GEM Premier 5000\nModel/Catalog Number: 00024019255\n\nIntelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system.", "code_info": "Lot Code: GEM Premier 5000:\nPart number: 00024019255\nUDI: 08426950870227\nUnits distributed in US: 0 affected BCR wands on the GEM Premier 5000 in the US. \nGEM Premier 5000 Serial Nos.: N/A\n\nUnits distributed in Hong Kong: 27 affected BCR wands on the GEM Premier 5000 in Hong Kong. \nGEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468.\n\nUnits distributed in United Kingdom: 67 affected BCR wands on the GEM Premier 5000 in the United Kingdom. \nGEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271.\n\nUnits distributed in Spain: 21 affected BCR wands on the GEM Premier 5000 in Spain. \nGEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710.\n\nUnits distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina. \nGEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897.\n\nAffected Accessory:\nBar Code Reader (BCR) Wand\nPart number: 00024019255\nUDI: 08426950870227\nUnits distributed in US: 0\nUnits distributed in Hong Kong: 27\nUnits distributed in Spain: 21\nUnits distributed in the United Kingdom: 67\nUnits distributed in Argentina: 3", "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": "BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the \"price check\" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.", "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": "0 US, 118 OUS", "distribution_pattern": "US Nationwide distribution.", "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" ] } } ] }