{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215934", "product_res_number": "Z-0107-2026", "event_date_initiated": "2025-09-03", "event_date_posted": "2025-10-09", "recall_status": "Open, Classified", "res_event_number": "97565", "product_code": "CEM", "k_numbers": [ "K121012" ], "product_description": "FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic", "code_info": "PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.", "firm_fei_number": "3010825766", "recalling_firm": "Inpeco S.A.", "address_1": "Via San Gottardo 10 10 via san gottardo", "city": "Lugano", "country": "Switzerland", "reason_for_recall": "The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.", "root_cause_description": "No Marketing Application", "action": "Consignees received an Urgent Medical Device Recall notification via email dated 9/3/25. The notification instructs consignees to not rely on HIL functionality for clinical decision making or to flag potentially erroneous samples. HIL functionality must be discontinued and cannot be disabled by users. Inspeco must send an Inspeco Servicer to consignee locations to disable HIL functionality. Inspeco will contact consingnees to schedule this service. Consignees are to forward the provided notification to those whom it might concern. Consignees with questions can contact Regulatory Affairs via email at regulatory.affairs@inspeco.com or Inspeco Service Team via email at service.NA@inspeco.com.", "product_quantity": "1 unit", "distribution_pattern": "US distribution to CA & NY.", "openfda": { "k_number": [ "K822441", "K112788", "K830104", "K032311", "K993083", "K915178", "K833696", "K112995", "K220396", "K915177", "K854723", "K061730", "K843008", "K961115", "K092686", "K833776", "K241037", "K840961", "K112412", "K851100", "K073157", "K853068", "K870657", "K800692", "K844044", "K851808", "K890792", "K883240", "K901039", "K791692", "K841575", "K052914", "K884769", "K200544", "K800054", "K897110", "K083680", "K912649", "K042291", "K970330", "K010061", "K884566", "K854298", "K842786", "K974784", "K121012", "K900788", "K853531", "K932044", "K842315", "K042270", "K853356", "K230890", "K013373", "K802158", "K843454", "K961326", "K121040", "K771118", "K844955", "K844806", "K840887", "K093318", "K896692", "K040750", "K800016", "K851350", "K915345", "K922943", "K092849", "K901041", "K895664", "K833159", "K253491", "K900300", "K832036", "K843239", "K790018", "K811310", "K870033", "K821822", "K771837", "K060373", "K112408", "K850950", "K110520", "K791175", "K923038", "K061107" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2", "registration_number": [ "", "9680746", "1000256526", "9610633", "8030478", "2250051", "1220649", "1319809", "2939693", "2245578", "3003637681", "3000308930", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "9614698", "2221819", "1219029", "3002807968", "1317202", "9610126", "3007490412", "1717966", "1219913", "2030861", "3003593973", "8020888", "3003030793", "2431530", "2247288", "3009473156", "3000126629", "1000455123", "3006198300", "1220972", "3004959793", "3023268435", "1319681", "3002809144", "3008244372", "3005643513", "9614673", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "8020316", "3003795116", "3009156722", "3002642396", "1222035", "3002637618", "3010825766", "2432235", "3007662974", "9612296", "3012963943", "9610816", "3016244760", "3011989923", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "3004378326", "3005333358", "1319436", "3007603826", "1181121", "3012817228", "2085064", "9610529", "3014506106", "3003971136" ], "fei_number": [ "", "1000256526", "2250051", "1220649", "2939693", "2245578", "3003637681", "3003559576", "3000308930", "3002808382", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "1000305840", "2221819", "1219029", "3002806560", "3002807968", "1317202", "3007490412", "1717966", "3002806559", "1219913", "3003593973", "3003030793", "2431530", "3009473156", "3000126629", "1000455123", "3006198300", "1000122044", "1000135102", "1220972", "3004959793", "3023268435", "1000120319", "3002809144", "3008244372", "3005643513", "3002806809", "3002806693", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "3003795116", "3009156722", "3002642396", "1222035", "3002637618", "3010825766", "3007019572", "2432235", "3007662974", "3002807167", "3012963943", "3016244760", "3002807663", "3011989923", "3001576181", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "1000136573", "3000215862", "3004378326", "1000206808", "3005333358", "3007603826", "1181121", "3012817228", "3014506106", "3003971136" ] } } ] }