{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "187793", "product_res_number": "Z-2026-2021", "event_date_initiated": "2021-05-13", "event_date_created": "2021-07-07", "recall_status": "Open, Classified", "res_event_number": "88056", "product_code": "JGS", "k_numbers": [ "K151767" ], "product_description": "Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens\nSMN 11067000", "code_info": "Effected SN Range: CM00902 - CM02065  Note: xxxx in serial number is any number.   UDI: 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": "Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.", "root_cause_description": "Component design/selection", "action": "Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021.\n\nLetter states:\nActions to be Taken by the Customer\nThe following actions must be taken until your system has been serviced to replace any leaking\ncomponents.\n1. When reporting results, ensure that all QC results are within the laboratory acceptable\nrange before releasing results.\nA manufacturing defect in some valves may cause them to leak\nSiemens Healthcare Diagnostics Inc.\n2. On the Atellica CH930 Analyzer:\nIf any water droplets are observed on the tips of any Reaction Wash Station or Dilution Wash Station probes, contact Siemens service so that the instrument can be checked for valves that may be failing.\n3. On the Atellica IM 1300 or Atellica IM 1600 Analyzers:\nIf any water droplets are observed forming at the tips of any Reagent probes, contact Siemens service so that the instrument can be checked for valves that may be failing.\nPlease review this letter with your Medical Director.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nIf you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Technical Support representative.\nSiemens Service representative will be contacting your laboratory to check and replace the identified valves.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\nContact your Siemens Healthineers Customer Care Center or y", "product_quantity": "US: 210\tOUS: 874", "distribution_pattern": "Nationwide\nForeign:\nCountry Name\nAlgeria\nArgentina\nAustralia\nAustria\nBahrain\nBangladesh\nBelgium\nBrazil\nBulgaria\nBurkina Faso\nCanada\nChile\nColombia\nCroatia\nCura¿ao\nCyprus\nCzech Republic\nDenmark\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nGermany\nGreece\nHungary\nIndia\nIndonesia\nIraq\nIreland\nIsrael\nItaly\nJapan\nKenya\nKuwait\nLatvia\nLibya\nLithuania\nMalaysia\nMexico\nMorocco\nNetherlands\nNew Zealand\nNorway\nOman\nP.R. China\nPakistan\nPeru\nPhilippines\nPoland\nPortugal\nQatar\nRepublic Korea\nRomania\nRussian Fed.\nSaudi Arabia\nSingapore\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTaiwan\nThailand\nTurkey\nU.A.E.\nUganda\nUkraine\nUnited Kingdom\nUruguay\nVatikancity\nVietnam", "openfda": { "k_number": [ "K852595", "K811289", "K161954", "K882104", "K844587", "K801795", "K061597", "K844559", "K894218", "K832070", "K895672", "K172232", "K830588", "K901042", "K923806", "K932179", "K962334", "K863907", "K925612", "K800584", "K924547", "K191365", "K811896", "K963627", "K874832", "K812762", "K873126", "K052724", "K020364", "K222438", "K940194", "K872190", "K874185", "K843530", "K905600", "K023049", "K822039", "K840557", "K180428", "K800676", "K963763", "K100673", "K842873", "K875263", "K123726", "K102959", "K800216", "K992842", "K904335", "K961099", "K213486", "K841417", "K053165", "K183549", "K895936", "K011213", "K001154", "K870183", "K833072", "K200403", "K882801", "K801896", "K861696", "K160370", "K002855", "K830589", "K082462", "K002407", "K933862", "K081411", "K802155", "K843453", "K924471", "K771839", "K993211", "K894914", "K820395", "K852473", "K941400", "K140373", "K863617", "K833712", "K252475", "K921718", "K912016", "K070104", "K871028", "K153357", "K841418", "K903564", "K132418", "K955375", "K881255", "K151767", "K091861", "K183688", "K864862", "K910305", "K915176", "K892500", "K833036", "K800628", "K896526", "K220977", "K863521", "K990346", "K952179", "K880917", "K873074", "K861967", "K791691", "K935120", "K051646", "K990036", "K925611", "K861087", "K810135", "K963542", "K992844", "K901040", "K910554", "K912560", "K853832", "K160225", "K832415", "K181201", "K102647", "K921937", "K880750", "K770601", "K833992", "K933373", "K841424", "K843452", "K905264", "K894035", "K832744", "K000895", "K001761", "K801011", "K100829", "K955374", "K053110", "K801007", "K040971", "K914810", "K161837", "K922215", "K801882", "K864872", "K862819", "K171476", "K872716", "K230275", "K850209", "K040977", "K903188", "K912648", "K842025", "K912387", "K121140", "K912559" ], "registration_number": [ "3003637681", "1000455123", "2050012", "2030861", "3005146313", "3023162659", "9680746", "3023268435", "8020888", "3002807877", "3037000637", "1319681", "3015997711", "3003795116", "3005509212", "3004493545", "3000148879", "3012963943", "1220649", "3007603826", "3014506106", "3013513377", "3012817228", "8020316", "1217183", "3007490412", "3003593973", "9610529", "2939693", "2431530", "3008244372", "9614698", "3002807968", "3004102403", "3002642396", "2250051", "2050010", "3012104670", "3003971136", "2221819", "3004438098", "2247288", "1319436", "3004959793", "3011989923", "3000308930", "1000256526", "3002637618", "3009156722", "3009473156", "1317202", "8030478", "9612296", "3002809144", "3016244760", "1219913", "1222035", "1000414342", "2245578", "9610816", "3006198300", "3016438761", "3008629785", "1616487", "1319809", "3003030793", "1036223", "9610633", "3014607865", "3004378326", "3005333358", "2517506", "1717966", "2085064", "3010324880", "9610126", "1827821", "3000126629", "1181121", "1036362", "3007662974", "3010825766", "1220972", "1219029", "9614673", "2432235", "3005643513" ], "fei_number": [ "1000120319", "3003637681", "1000455123", "2050012", "3005146313", "3023162659", "1000135102", "3023268435", "3002807877", "3037000637", "3015997711", "3003795116", "3005509212", "3004493545", "3000148879", "3002807167", "3007019572", "3012963943", "3002807663", "1220649", "3007603826", "1000122044", "3014506106", "1000305840", "3002808382", "3013513377", "3012817228", "3002806560", "3007490412", "3003593973", "1217183", "2939693", "2431530", "3008244372", "3002807968", "3004102403", "3002642396", "2250051", "2050010", "3012104670", "3003971136", "2221819", "3004438098", "3001576181", "3000215862", "3004959793", "3011989923", "3000308930", "1000256526", "3002637618", "3009156722", "3003559576", "3009473156", "1317202", "3002809144", "3016244760", "1219913", "1222035", "1000136573", "1000414342", "2245578", "1000206808", "3002806559", "3006198300", "3016438761", "3008629785", "1616487", "3003030793", "1036223", "3014607865", "3004378326", "3005333358", "3002806809", "2517506", "1717966", "3010324880", "1827821", "3000126629", "1181121", "1036362", "3007662974", "3010825766", "1220972", "1219029", "2432235", "3002806693", "3005643513" ], "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ] }