{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221458", "product_res_number": "Z-2890-2026", "event_date_initiated": "2026-07-06", "event_date_posted": "2026-08-05", "recall_status": "Open, Classified", "res_event_number": "99389", "product_code": "JIR", "product_description": "Atellica CH Urine Albumin\nREF: 11537225", "code_info": "All Lots within expiry/UDI: 00630414611099", "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": "Customer Care\n914-631-8000", "reason_for_recall": "processing Atellica CH Urine Albumin (UAlb)\ntests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely\ndepressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH\nEnzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC\nfailures and Delayed results due to QC failures.", "root_cause_description": "Under Investigation by firm", "action": "On July 6, 2026, Siemens Healthineers issued a Urgent Medical Device Recall to affected consignees via Fed Ex. Siemens Healthineers ask consignees to take the following actions: \n\n1. Discontinue Atellica CH Urine Albumin (UAlb) testing and transition to the Atellica CH\nMicroalbumin_2 (ALB_2) reagent, SMN 11097610, and Atellica CH Microalbumin_2\nCalibrator (ALB_2 CAL), SMN 11099435, as an alternate test solution.\n2. Replace all reaction cuvette segments following discontinuation of UAlb testing. Refer to\nthe Atellica Solution Online Help for instructions on replacing reaction cuvette segments.\n3. Complete the Field Correction Effectiveness Check Form attached to this letter and return\nwithin 30 days.\n4.Credit will be issued for unexpired UAlb reagent (SMN 11537225), UAlb calibrator (SMN\n11537247), and reaction cuvettes segments, as applicable.\n5. Please review this letter with your Medical Director to determine the appropriate course\nof action, including whether review of any previously generated results is warranted.\n6. Please retain this letter with your laboratory records and forward this letter to those who\nmay have received the affected product.", "product_quantity": "7018 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Cura¿ao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿", "openfda": { "k_number": [ "K222921", "K890846", "K894169", "K972960", "K061419", "K210069", "K960274", "K001810", "K912543", "K912246", "K811219", "K932950", "K884146", "K882538", "K970932", "K955438", "K891544", "K904752", "K885053", "K983774", "K982219", "K992257", "K851338", "K991315", "K934146", "K830977", "K874909", "K963142", "K922032", "K951222", "K896440", "K994035", "K902204", "K920216", "K150330", "K022538", "K954346", "K972337" ], "registration_number": [ "3008517993", "3002806944", "3013679502", "3015921024", "2432235", "2531491", "3005360469", "3015341499", "3013298431", "3003795116", "2029372", "3010891909", "3003917514", "3038206980", "2025099", "1181121", "1219029", "1832816", "3003422726", "3002800697", "3009238284", "3010564249", "3006621318", "9615507", "1832216", "9610633", "9611444", "3030446844", "3006479639", "3012421607", "2122870", "3005841640", "1419699", "1036362", "3021186226", "3043127699", "3009448641", "9710094", "3013660430", "3007301207", "3006198300", "3016712364", "3034731501", "2030633", "3004493545", "3010324880", "3008058135", "3014150341", "3011689956", "1649661", "4580", "3004192065", "3013545943", "2244821", "9610126", "3014255036", "3024171133", "3012494290", "9680746", "1616487", "9613069", "3002637618", "2245285", "1061932", "8040374", "1417592", "3008987086", "3024463179", "3004043187", "3042471840", "3007126977", "3003741796", "3031915160" ], "fei_number": [ "3008517993", "3002806944", "3013679502", "3015921024", "2432235", "3002829675", "3005670738", "3015341499", "3013298431", "3003795116", "3010891909", "3003917514", "3038206980", "3003045237", "1181121", "1219029", "1832816", "3003422726", "3002800697", "3009238284", "3003347234", "3010564249", "3006621318", "1832216", "3003516723", "3030446844", "3006479639", "3012421607", "2122870", "3005841640", "1419699", "1036362", "3021186226", "3043127699", "3009448641", "3013660430", "3007301207", "3006198300", "3016712364", "3034731501", "5864", "3004493545", "3010324880", "3008058135", "3014150341", "3011689956", "4580", "3000203293", "3007981058", "3004192065", "3013545943", "2244821", "3014255036", "3024171133", "1616487", "3012494290", "3002806693", "3001451797", "1000206808", "3002807423", "1000306617", "3002637618", "2245285", "1417592", "3008987086", "3024463179", "3000210620", "3004043187", "3002806559", "3042471840", "3007126977", "3003741796", "3031915160" ], "device_name": "Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1645", "device_class": "1" } } ] }