{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190656", "product_res_number": "Z-0449-2022", "event_date_initiated": "2021-11-18", "event_date_created": "2022-01-03", "recall_status": "Open, Classified", "res_event_number": "89160", "product_code": "JGS", "k_numbers": [ "K151767" ], "product_description": "Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. \nSiemens Material Number (SMN): 11067000", "code_info": "Software version: V1.25.1 and lower.\nUDI: 00630414002163", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "SAME\n914-631-8000", "reason_for_recall": "(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results", "root_cause_description": "Software design", "action": "Siemens issued Urgent Medical Device Correction (UMDC), ASW22-01.A.US, to US customers by FedEx beginning on November 18th, 2021. \tAn Urgent Field Safety Notice (UFSN), ASW22-01.A.OUS, was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 2021/11/18.\nLetter states reason for recall, health risk and action to take:\nThe following actions must be taken until your system has been updated to a software version which resolves the issues mentioned in Table 2 above. Siemens Healthineers will notify you when an updated software version is available.\nIssue 1. TDef Parameters reverting to Default Values\nWhen saving changes in the Open Channel configuration screen, saving the screen will reset TDef parameter to default settings. To correct this behavior, navigate back to the TDef screen (Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct (refer to Table 3):\nx Definition Tab (General)\nx Definition Tab (Measuring Intervals)\nx Calculation (General)\nx Calculation (HIL Alert Indices)\nx Calculation (Assay Comparison Correlation Factor)\nx Calibration\nThere is no need to go back to the Open Channel configuration screen after the TDef\nparameters have been confirmed to be correct or corrected. If navigating back to the Open Channel configuration screen and saving, please repeat above steps.\nIssue 2. On Board Stability (OBS) Not Updating with Manual Changes\nIssue 1. TDef Parameters reverting to Default Values\nWhen saving changes in the Open Channel configuration screen, saving the screen will reset\nTDef parameter to default settings. To correct this behavior, navigate back to the TDef screen\n(Setup>Test Definition>CH Test Definition) and ensure that all TDef parameters are correct\n(refer to Table 3):\nx Definition Tab (General)\nx Definition Tab (Measuring Intervals)\nx Calculation (General)\nx Calculation (HIL Alert Indices)\nx Calc", "product_quantity": "2,980 units", "distribution_pattern": "Nationwide\nForeign:\nAU\nDE\nAE\nTR\nBG\nCL\nIN\nCZ\nBR\nES\nKE\nCN\nPL\nSA\nBE\nIQ\nIT\nCW\nSE\nAR\nCO\nGR\nSK\nEE\nKR\nJP\nUY\nDK\nFR\nGB\nVN\nCA\nBD\nMX\nTH\nDZ\nPT\nRU\nZA\nPK\nHU\nNL\nVA\nNO\nAT\nIR\nLV\nEG\nPH\nSG\nMY\nIL\nFI\nHR\nMA\nKW\nCH\nTW\nBH\nAL\nBF\nUG\nNZ\nOM\nHK\nQA\nPE\nEC\nIE\nGP\nLY\nLT", "openfda": { "k_number": [ "K771839", "K963763", "K811289", "K091861", "K811896", "K894035", "K864872", "K952179", "K861087", "K040977", "K993211", "K905264", "K870183", "K874832", "K940194", "K171476", "K800584", "K990346", "K895672", "K864862", "K912559", "K832415", "K833072", "K160370", "K881255", "K213486", "K100673", "K955374", "K895936", "K000895", "K910305", "K153357", "K912016", "K894218", "K011213", "K801896", "K892500", "K842873", "K061597", "K801795", "K222438", "K921937", "K875263", "K861967", "K924471", "K990036", "K801011", "K843452", "K812762", "K882801", "K833036", "K992844", "K181201", "K802155", "K863617", "K872716", "K151767", "K932179", "K912648", "K183549", "K863907", "K770601", "K925611", "K844559", "K801007", "K102959", "K921718", "K912560", "K102647", "K082462", "K903188", "K132418", "K841418", "K912387", "K933862", "K172232", "K935120", "K020364", "K843530", "K992842", "K023049", "K220977", "K844587", "K001761", "K160225", "K963627", "K820395", "K874185", "K843453", "K850209", "K955375", "K800676", "K862819", "K905600", "K933373", "K961099", "K183688", "K873126", "K230275", "K822039", "K901040", "K853832", "K901042", "K180428", "K140373", "K052724", "K962334", "K914810", "K904335", "K833992", "K100829", "K841417", "K861696", "K053110", "K161954", "K830589", "K896526", "K800216", "K121140", "K081411", "K123726", "K863521", "K924547", "K002407", "K852595", "K791691", "K841424", "K832744", "K941400", "K252475", "K925612", "K830588", "K840557", "K810135", "K873074", "K191365", "K963542", "K903564", "K923806", "K910554", "K882104", "K922215", "K852473", "K872190", "K070104", "K053165", "K833712", "K001154", "K871028", "K002855", "K894914", "K880750", "K040971", "K801882", "K915176", "K842025", "K200403", "K880917", "K161837", "K800628", "K832070", "K051646" ], "registration_number": [ "1827821", "9610633", "2030861", "9614698", "1217183", "1616487", "2939693", "3010324880", "1181121", "3007603826", "3016438761", "3002642396", "3003971136", "1717966", "3007490412", "2517506", "3014607865", "9614673", "3014506106", "2431530", "2432235", "9610529", "3037000637", "3006198300", "3008244372", "8020888", "3002807968", "3003030793", "9680746", "2050010", "1222035", "1319681", "3023268435", "3010825766", "8020316", "3012963943", "1319436", "2050012", "1036362", "3008629785", "9610816", "3004493545", "2245578", "3002807877", "9610126", "3016244760", "1220972", "3003637681", "2250051", "3002637618", "1319809", "3011989923", "9612296", "3000126629", "1000414342", "3000148879", "3015997711", "1219029", "3004378326", "3007662974", "3004102403", "3009473156", "3004438098", "2085064", "3023162659", "3013513377", "3005333358", "3005643513", "3004959793", "8030478", "1000455123", "3005509212", "2247288", "3012817228", "3012104670", "3009156722", "1317202", "3003795116", "3002809144", "1219913", "2221819", "1036223", "1220649", "3003593973", "3000308930", "1000256526" ], "fei_number": [ "1827821", "1000120319", "1217183", "1000305840", "1000206808", "1616487", "2939693", "3010324880", "1181121", "3007603826", "3016438761", "3002642396", "3003971136", "1717966", "3007490412", "2517506", "3014607865", "3014506106", "2431530", "2432235", "3037000637", "3006198300", "3008244372", "3002807968", "3003030793", "3002806560", "3002807167", "2050010", "3002806809", "3007019572", "1222035", "3023268435", "3010825766", "3012963943", "2050012", "3002808382", "1036362", "3008629785", "3001576181", "3004493545", "2245578", "3002807877", "3016244760", "3002806693", "1220972", "3002806559", "3002807663", "3003637681", "2250051", "3002637618", "3011989923", "3000126629", "1000414342", "3000215862", "3000148879", "3015997711", "1219029", "3004378326", "3007662974", "3004102403", "3009473156", "3004438098", "3023162659", "3013513377", "3005333358", "1000135102", "3005643513", "3003559576", "3004959793", "1000136573", "1000455123", "3005509212", "3012817228", "1000122044", "3012104670", "3009156722", "1317202", "3003795116", "3002809144", "1219913", "2221819", "1036223", "1220649", "3003593973", "3000308930", "1000256526" ], "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ] }