{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "216968", "product_res_number": "Z-0595-2026", "event_date_initiated": "2025-10-30", "event_date_posted": "2025-11-26", "recall_status": "Open, Classified", "res_event_number": "97887", "product_code": "CEM", "k_numbers": [ "K121012" ], "product_description": "FlexLab (FLX);\nVersion: FLX-217-10;", "code_info": "UDI-DI: 07640172340004\nSerial number: FLX.0226;", "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 Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of\nmALX to perform error recoveries or maintenance procedures and do not empty the printer\ntubes buffer to remove all the secondary sample tubes.", "root_cause_description": "Device Design", "action": "On October 30, 2025, \"Urgent: Medical Device Correction\" letters were sent to customers. Action to be taken: To avoid the occurrence of the described issue Inpeco recommends removing all the secondary sample tubes in the printer tubes buffer (red arrow) each time the printer cover (blue arrow) is opened for error recoveries and for preventive maintenance procedures. Your service provider will contact you to schedule the service visit to implement the corrective actions which include the installation of a new sensor, the software and firmware upgrade, and the operations manual update. \n\nTransmission of this Customer Letter:\nUntil the service visit, please maintain awareness on this notice and apply the action\nrecommended above.\n\nPlease transfer this notice to whom it might concern.\nPlease complete and return the Customer Letter Receipt Confirmation and Implementation Check form attached to this letter within 30 days directly to the email address specified in the email communication.\n\nIf you have any questions, contact the Regulatory Affairs Department via email: regulatory.affairs@inpeco.com.", "product_quantity": "1 unit (OUS only)", "distribution_pattern": "US Domestic: MI.\nOUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.", "openfda": { "k_number": [ "K870033", "K961115", "K802158", "K832036", "K791175", "K900300", "K073157", "K970330", "K220396", "K092686", "K843454", "K842786", "K895664", "K032311", "K083680", "K842315", "K200544", "K833696", "K822441", "K013373", "K993083", "K870657", "K840961", "K884566", "K800054", "K052914", "K961326", "K811310", "K900788", "K915178", "K833159", "K853068", "K896692", "K922943", "K830104", "K061730", "K901041", "K844806", "K771837", "K915177", "K833776", "K791692", "K042270", "K092849", "K851350", "K112995", "K112408", "K851100", "K800692", "K112412", "K093318", "K851808", "K790018", "K112788", "K241037", "K854298", "K853531", "K121040", "K844044", "K843008", "K253491", "K771118", "K230890", "K010061", "K850950", "K884769", "K915345", "K923038", "K042291", "K932044", "K821822", "K854723", "K843239", "K844955", "K897110", "K974784", "K841575", "K121012", "K883240", "K040750", "K800016", "K061107", "K840887", "K912649", "K060373", "K110520", "K901039", "K890792", "K853356" ], "registration_number": [ "3006198300", "3005643513", "9614673", "1317202", "2050012", "2030861", "3004959793", "3014607865", "2517506", "3002642396", "2250051", "3007490412", "3004493545", "3010324880", "1222035", "9612296", "3007603826", "3023162659", "1319809", "3012817228", "9614698", "3016438761", "1217183", "1220649", "9610816", "9610633", "3002809144", "1616487", "2085064", "3009156722", "3007662974", "3009473156", "3002807968", "2432235", "3023268435", "1319681", "1036362", "3000148879", "1827821", "1000414342", "2247288", "3000126629", "3010825766", "3004102403", "1181121", "1319436", "3037000637", "2245578", "3000308930", "1000256526", "3002807877", "3012963943", "1219029", "1220972", "1000455123", "3014506106", "2050010", "3003795116", "3003593973", "8020888", "3003030793", "3016244760", "9610126", "1036223", "3002637618", "1219913", "2431530", "3004438098", "8030478", "9680746", "3005509212", "3003637681", "3004378326", "8020316", "3011989923", "9610529", "3008244372", "1717966", "2939693", "3003971136", "3005333358", "2221819", "3013513377" ], "fei_number": [ "3006198300", "3005643513", "1317202", "2050012", "3004959793", "3014607865", "2517506", "3007019572", "3002642396", "2250051", "3007490412", "3004493545", "3010324880", "1222035", "3007603826", "3023162659", "3012817228", "3016438761", "1217183", "1220649", "3002806693", "3000215862", "3002809144", "1616487", "3009156722", "3007662974", "3009473156", "3002807968", "2432235", "3002806809", "3023268435", "3002807663", "3001576181", "1036362", "1000305840", "1000135102", "3002807167", "3003559576", "3000148879", "1827821", "1000414342", "3000126629", "3010825766", "3004102403", "1181121", "3002808382", "3037000637", "1000120319", "2245578", "3000308930", "1000256526", "3002807877", "3012963943", "1219029", "1000206808", "1220972", "1000455123", "1000122044", "3014506106", "2050010", "3002806559", "3003795116", "3003593973", "3002806560", "3003030793", "3016244760", "1036223", "3002637618", "1000136573", "1219913", "2431530", "3004438098", "3005509212", "3003637681", "3004378326", "3011989923", "3008244372", "1717966", "2939693", "3003971136", "3005333358", "2221819", "3013513377" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2" } } ] }