{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219420", "product_res_number": "Z-2005-2026", "event_date_initiated": "2026-04-02", "event_date_posted": "2026-04-29", "recall_status": "Open, Classified", "res_event_number": "98680", "product_code": "CHL", "k_numbers": [ "K200107" ], "product_description": "epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; \nSiemens Material Number (SMN): 10736515;", "code_info": "Siemens Material Number (SMN): 10736515; \nUDI-DI: 00809708121860; \nLot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only);", "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": "Customer Service USA\n877-229-3711", "reason_for_recall": "Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.", "root_cause_description": "Under Investigation by firm", "action": "On April 2, 2026, Urgent Medical Device Recall letters were sent to customers.\nActions to be taken: Perform the instructions provided below:\n\" Discontinue use of and discard the kit lots listed in the table above (Products Section).\n\" Please review this letter with your Medical Director/POC Coordinator to determine the appropriate\ncourse of action, including for any previously generated results, if applicable.\n\" Complete and return the Field Correction Effectiveness Check Form and Product Replacement Form\nattached to this letter within 30 days.\n\" Adverse reactions or quality problems experienced with the use of this product may be reported to\nthe FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.\n\" Please retain this letter with your laboratory records and forward this letter to those who may have\nreceived this product.\n\" For any questions, you may call Siemens Healthineers Technical Solutions Center at 877- 229-3711,\navailable daily from 7:00 AM to 11:00 PM EST.", "product_quantity": "71725 (38025 US, 33700 OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.", "openfda": { "k_number": [ "K061974", "K974526", "K122729", "K944089", "K936081", "K831015", "K820744", "K953935", "K002738", "K022746", "K832981", "K842519", "K936203", "K994346", "K151978", "K781968", "K123748", "K813517", "K080370", "K223857", "K854608", "K991417", "K942616", "K141907", "K002290", "K914560", "K760748", "K160153", "K963800", "K890827", "K240998", "K955793", "K110416", "K831023", "K881188", "K844781", "K940918", "K961161", "K840843", "K771253", "K945240", "K810308", "K800224", "K133407", "K151856", "K904188", "K131126", "K771147", "K934907", "K151982", "K961657", "K850360", "K200492", "K831024", "K780716", "K200107", "K974396", "K800271", "K833534", "K943882", "K993789", "K792230", "K221900", "K831017", "K093280", "K954711", "K031560", "K853405", "K970710", "K853840", "K882941", "K831025", "K831010", "K833536", "K142898", "K023567", "K946206", "K935830", "K192240", "K992859", "K884267", "K252207", "K831020", "K821483", "K831021", "K914166", "K982928", "K014295", "K963964", "K050423", "K973367", "K904513", "K834601", "K810724", "K823570", "K932642", "K110648", "K961335", "K954612", "K820597", "K852790", "K980991", "K984384", "K000103", "K120197", "K812623", "K891578", "K865036", "K131988", "K943643", "K864445", "K913927", "K954482", "K173797", "K812090", "K230285", "K200986", "K211559", "K831012", "K831016", "K130144", "K823750", "K193246", "K063376", "K244014", "K935069", "K831379", "K142220", "K915087", "K902267", "K770736", "K980523", "K844295", "K043218", "K122642", "K871397", "K980130", "K012478", "K831018", "K935655", "K943570", "K122539", "K992834", "K002613", "K131703", "K800757", "K051804", "K760229", "K922631", "K882209", "K860057", "K772307", "K903965", "K223608", "K884143", "K863880", "K895181", "K962021", "K831019", "K832779", "K982277", "K840300", "K111188", "K111897", "K812552", "K020297", "K924758", "K935121", "K012058", "K100777", "K160412", "K021713", "K990092", "K760969", "K041874", "K203790", "K895317", "K013729", "K831013", "K021515", "K873577", "K924497", "K922922", "K173403", "K841609", "K840468", "K852676", "K771822" ], "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": [ "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "9610633", "8030478", "3014506106", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "9610126", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ], "fei_number": [ "3002806559", "1219913", "3005643513", "3015997711", "2245578", "3007662974", "3002637618", "3012104670", "3002807968", "1220649", "2432235", "1220972", "1000455123", "1717966", "3002806693", "3014506106", "3001576181", "1217183", "1036362", "3012817228", "2050012", "3023162659", "3013513377", "3004959793", "3004102403", "1222035", "3006198300", "2431530", "1219029", "3037000637", "3003795116", "3003971136", "1181121", "3007490412" ] } } ] }