{"recall":{"id":"fda-device-99115","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Instrumentation Laboratory recalls 6 products","firm":"Instrumentation Laboratory","date":"2026-05-08","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part No. 00024015859","code":"GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227 GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924 Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"122","number":"Z-2821-2026","classification":"Class II"},{"name":"Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer","code":"GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"4 US","number":"Z-2822-2026","classification":"Class II"},{"name":"Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system","code":"GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: GEM 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. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"27","number":"Z-2823-2026","classification":"Class II"},{"name":"Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system","code":"GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: GEM 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. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"67","number":"Z-2824-2026","classification":"Class II"},{"name":"Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system","code":"GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Spain: GEM 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. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"21","number":"Z-2825-2026","classification":"Class II"},{"name":"Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system","code":"GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634","quantity":"3","number":"Z-2826-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"122; 4 US; 27; 67; 21; 3","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=99115","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3580e23559a6fd9c","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=99115","record":[{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2821-2026","product_description":"GEM Premier 5000 with IQM2  Model/Catalog Number: 00024019255 and  GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279   Portable blood analyzer system.    Affected Accessory:   Bar Code Reader (BCR) Wand Part No. 00024015859","product_quantity":"122","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 5000 Part number: 00024019255, UDI: 08426950870227   GEM Premier 7000 Part number: 00000015279, UDI: 0195226000924    Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634"},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2822-2026","product_description":"Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279  Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. portable blood analyzer","product_quantity":"4 US","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US:    GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070.  Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2823-2026","product_description":"Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255    portable blood analyzer system","product_quantity":"27","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 5000:  Part number: 00024019255  UDI: 08426950870227  Units distributed in Hong Kong:    GEM 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.  Affected Accessory:  Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2824-2026","product_description":"Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255   portable blood analyzer system","product_quantity":"67","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 5000:  Part number: 00024019255  UDI: 08426950870227  Units distributed in United Kingdom:   GEM 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.  Affected Accessory:  Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2825-2026","product_description":"Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255   Portable blood analyzer system","product_quantity":"21","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 5000:  Part number: 00024019255  UDI: 08426950870227  Units distributed in Spain:    GEM 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.  Affected Accessory:  Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"},{"status":"Ongoing","city":"Bedford","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99115","recalling_firm":"Instrumentation Laboratory","address_1":"180 Hartwell Rd","address_2":"N/A","postal_code":"01730-2443","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2826-2026","product_description":"Brand Name: GEM Premier 5000  Product Name: GEM Premier 5000  Model/Catalog Number: 00024019255   Portable blood analyzer system","product_quantity":"3","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.","recall_initiation_date":"20260508","center_classification_date":"20260729","report_date":"20260805","code_info":"GEM Premier 5000:  Part number: 00024019255   UDI: 08426950870227  Units distributed in Argentina:   GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897.   Affected Accessory:  Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026.  Part No. 00024015859; UDI No. 08426950869634"}]}}