{ "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": 1 } }, "results": [ { "cfres_id": "194382", "product_res_number": "Z-1372-2022", "event_date_initiated": "2022-06-01", "event_date_created": "2022-07-12", "recall_status": "Open, Classified", "res_event_number": "90432", "product_code": "CHL", "k_numbers": [ "K192240" ], "product_description": "epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood\nProduct Siemens SMN#/Model #: 10736515", "code_info": "UDI-DI: 00809708121860 Lot Number: 11-22005-50  Exp. Date: 22-June-2022", "firm_fei_number": "3002637618", "recalling_firm": "Siemens Healthcare Diagnostics Inc", "address_1": "2 Edgewater Dr", "city": "Norwood", "state": "MA", "postal_code": "02062-4637", "additional_info_contact": "SAME\n781-269-3000", "reason_for_recall": "Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.", "root_cause_description": "Under Investigation by firm", "action": "Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US\n via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take:\nPlease dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your\npossession in accordance with local and state disposal requirements. You may request free of\ncharge replacement product from your local Siemens or distributor office. Please review your\ninventory of this product and assess your laboratory s replacement needs.\n Please use an epoc BGEM test card from another unaffected lot.\n Review this letter with your Medical Director.\n Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter.\nPlease retain this letter with your laboratory records and forward it to those who may have received this product.\n\nQuestions contact your Siemens Customer Care Center or your local Siemens technical support representative.", "product_quantity": "263 Boxes", "distribution_pattern": "AL\nCA\nCO\nFL\nIA\nID\nKS\nNM\nOK\nTX", "openfda": { "k_number": [ "K973367", "K812090", "K932642", "K800224", "K914560", "K974396", "K865036", "K021515", "K093280", "K831025", "K832981", "K014295", "K021713", "K903965", "K940918", "K922922", "K820744", "K842519", "K891578", "K023567", "K110416", "K992859", "K244014", "K031560", "K193246", "K943570", "K895181", "K852676", "K203790", "K151856", "K834601", "K200492", "K771253", "K980991", "K831015", "K963800", "K771147", "K051804", "K994346", "K013729", "K211559", "K840300", "K871397", "K812623", "K882209", "K935069", "K946206", "K852790", "K810724", "K895317", "K122729", "K173797", "K882941", "K860057", "K110648", "K120197", "K000103", "K223608", "K813517", "K980523", "K820597", "K922631", "K840843", "K954482", "K002613", "K831012", "K800271", "K935830", "K963964", "K945240", "K760748", "K990092", "K061974", "K821483", "K080370", "K884143", "K131126", "K881188", "K792230", "K780716", "K924497", "K844295", "K980130", "K935655", "K043218", "K831024", "K873577", "K943882", "K853840", "K173403", "K122539", "K160412", "K904513", "K122642", "K935121", "K002290", "K800757", "K914166", "K111897", "K142898", "K954612", "K760229", "K982277", "K993789", "K200986", "K991417", "K771822", "K760969", "K770736", "K943643", "K942616", "K252207", "K850360", "K131988", "K992834", "K831016", "K012478", "K050423", "K160153", "K833536", "K772307", "K151982", "K230285", "K832779", "K936203", "K944089", "K100777", "K041874", "K955793", "K831020", "K844781", "K240998", "K853405", "K823750", "K841609", "K151978", "K831018", "K961657", "K924758", "K111188", "K831021", "K864445", "K831023", "K953935", "K974526", "K863880", "K934907", "K954711", "K831017", "K840468", "K982928", "K831379", "K854608", "K781968", "K223857", "K884267", "K936081", "K192240", "K123748", "K984384", "K002738", "K142220", "K022746", "K970710", "K810308", "K141907", "K131703", "K961335", "K831013", "K962021", "K221900", "K902267", "K831019", "K133407", "K961161", "K812552", "K200107", "K904188", "K012058", "K823570", "K130144", "K913927", "K890827", "K020297", "K063376", "K831010", "K833534", "K915087" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "2432235", "3006198300", "3005643513", "3015997711", "2050012", "3002637618", "3004959793", "1219913", "2431530", "2245578", "3007490412", "1036362", "1219029", "1222035", "8030478", "1220972", "3023162659", "1000455123", "3012817228", "1217183", "3014506106", "1220649", "3003795116", "3012104670", "1717966", "9610633", "3004102403", "3003971136", "3007662974", "1181121", "3002807968", "3013513377", "3037000637", "9610126" ], "fei_number": [ "2432235", "3006198300", "3005643513", "3015997711", "2050012", "3002637618", "3004959793", "1219913", "2431530", "2245578", "3007490412", "3001576181", "1036362", "1219029", "1222035", "1220972", "3023162659", "1000455123", "3012817228", "1217183", "3014506106", "1220649", "3002806559", "3003795116", "3002806693", "3012104670", "1717966", "3004102403", "3003971136", "3007662974", "1181121", "3002807968", "3013513377", "3037000637" ] } } ] }