{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203444", "product_res_number": "Z-0200-2024", "event_date_initiated": "2023-09-06", "event_date_posted": "2023-10-31", "recall_status": "Open, Classified", "res_event_number": "93102", "product_code": "CEM", "k_numbers": [ "K052914" ], "product_description": "RX Imola-IVD Clinical Chemistry Analyzer\nCatalog Number: RX4900. RX4900R (refurbished)", "code_info": "GTIN: 05055273206104\nLot/Batch Number:\n(1)\n7201-0747\n7201-0423\n7201-0417\n7201-0353\n7255-0198\n7255-0172\n7255-0171\n7255-0129\n7201-1085\n7201-1086\n7201-1079\n7201-1080\n7201-0982\n7201-0977\n7201-0970\n7201-0950\n7201-0924\n7201-0919\n7201-0901\n7201-0849\n7201-0827\n7201-0801\n7201-0768\n7201-0606\n7201-0562\n7201-0535\n7201-0531\n7201-0482\n\n(2)¿¿¿¿¿¿¿¿¿¿¿¿¿ \n7201-0776\n7201-0367\n7201-0343¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿\n7201-0348 ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿", "firm_fei_number": "1000361607", "recalling_firm": "Randox Laboratories Ltd.", "address_1": "55 Diamond Road", "city": "Crumlin", "state": "North", "country": "Ireland", "reason_for_recall": "RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i\nissues with the re-run feature conditions when incorrectly. Potential to report incorrectly.", "root_cause_description": "Under Investigation by firm", "action": "Randox issued Medical Device Correction letter (REC687) on 9/13/23 to to US and PR customers on 9/12/23.\nLetter states reason for recall, health risk and action to take:\nRandox recommendations:\n\" Auto rerun settings are disabled, see Appendix A for guidance for each Rx instrument.\n\" Results with flag(<) reported as the bottom of the technical range. Sample Volume\nsettings Low should not be applied.\n\" Results with flag (>) reported as the top of the technical range. Sample Volume\nsettings high and dilutions should not be applied. A manual dilution should be\nperformed, and results multiplied by the dilution factor.\nThe RX Parameter rerun settings will be updated with a parameter release in due course, the Instructions For Use will also be updated at this time.\n\nAction to be taken:\n\" Discuss the contents of this notice with your Medical Director.\n\" Complete and return the response form 12187-QA to technical.services@randox.com\nwithin five working days.\nTransmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.", "product_quantity": "35 units", "distribution_pattern": "US Nationwide distribution including Puerto Rico", "openfda": { "k_number": [ "K811310", "K061107", "K061730", "K851808", "K832036", "K993083", "K083680", "K851100", "K112412", "K961115", "K843454", "K010061", "K842786", "K897110", "K800054", "K840887", "K843239", "K853356", "K974784", "K840961", "K800016", "K042291", "K844044", "K093318", "K073157", "K843008", "K220396", "K112408", "K121012", "K923038", "K110520", "K901039", "K884769", "K112995", "K791175", "K915177", "K821822", "K890792", "K896692", "K771118", "K253491", "K833696", "K092686", "K844806", "K791692", "K970330", "K854723", "K883240", "K241037", "K830104", "K915178", "K895664", "K802158", "K121040", "K052914", "K040750", "K851350", "K932044", "K853531", "K900300", "K915345", "K822441", "K042270", "K060373", "K771837", "K850950", "K842315", "K884566", "K854298", "K961326", "K870657", "K833159", "K853068", "K870033", "K833776", "K032311", "K112788", "K013373", "K900788", "K092849", "K922943", "K844955", "K901041", "K200544", "K790018", "K230890", "K800692", "K912649", "K841575" ], "registration_number": [ "", "3003795116", "1827821", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "9610126", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "2030861", "3002637618", "3005643513", "2431530", "3004959793", "1000455123", "2050012", "2221819", "1222035", "8020888", "3005509212", "2250051", "9614698", "3008244372", "3007662974", "3007490412", "1616487", "2085064", "3012817228", "1220972", "1036362", "3003593973", "9610633", "1319809", "1217183", "3007603826", "3014607865", "3016438761", "9610816", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "3023268435", "9680746", "3004493545", "3002807968", "1317202", "3004378326", "3013513377", "9610529", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "2247288", "1181121", "9614673", "3011989923", "1219913", "1319681", "3009156722", "8030478", "8020316", "9612296", "3004438098", "2939693", "1319436", "3000148879", "2517506", "3000126629" ], "fei_number": [ "", "3003795116", "1827821", "1000122044", "3004102403", "1000414342", "3002809144", "2432235", "1717966", "3009473156", "3003637681", "3010324880", "3000308930", "3003030793", "1000256526", "3006198300", "3002637618", "3005643513", "3003559576", "2431530", "3004959793", "3002807167", "3007019572", "3002807663", "3002806809", "1000455123", "2050012", "1000206808", "2221819", "1222035", "3005509212", "2250051", "3008244372", "3007662974", "3007490412", "1616487", "3012817228", "1220972", "1036362", "3003593973", "1217183", "3007603826", "3002808382", "3014607865", "3016438761", "3003971136", "3016244760", "3012963943", "3037000637", "3002642396", "3005333358", "1000120319", "1000305840", "3023268435", "3002806560", "3000215862", "3004493545", "3002807968", "1000136573", "1317202", "3004378326", "3001576181", "3002806559", "1000135102", "3013513377", "2245578", "3014506106", "3010825766", "3023162659", "1219029", "1036223", "2050010", "1220649", "1181121", "3011989923", "1219913", "3009156722", "3004438098", "2939693", "3002806693", "3000148879", "2517506", "3000126629" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2" } } ] }