{ "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": "218934", "product_res_number": "Z-1657-2026", "event_date_initiated": "2026-02-23", "event_date_posted": "2026-03-27", "recall_status": "Open, Classified", "res_event_number": "98498", "product_code": "PDJ", "k_numbers": [ "K200256" ], "product_description": "Atellica CH Enzymatic Hemoglobin A1c (A1c_E);\nSiemens Material Number (SMN): 11097536;", "code_info": "Siemens Material Number (SMN): 11097536;\nUDI-DI: 00630414220505;\nLot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;", "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": "Jennifer Sacks\n443-793-7288", "reason_for_recall": "A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU).\nWhen this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.", "root_cause_description": "Process control", "action": "On February 23, 2026 Urgent Medical Device Correction letters were sent to customers. \nActions required: If your laboratory is not processing RCRP and A1c_E on the same analyzer, no action is required. If your laboratory is processing RCRP and A1c_E on the same analyzer, monitor A1c_E QC for evidence of negative bias and increased imprecision. Please review this letter with your Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nRetain this letter with your laboratory records and forward it to others who may have\nreceived this product.\nResolution A follow-up communication will be provided when Customer Actions are no longer required. We appreciate your continued partnership and apologize for any inconvenience this situation\nmay cause. If you have any questions or require assistance, please contact your Siemens\nHealthineers Customer Care Center or your local technical support representative.", "product_quantity": "21,291 units (9750 US, 11541 OUS)", "distribution_pattern": "Domestic: Nationwide Distribution\n\nInternational: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;", "openfda": { "k_number": [ "K173206", "K161687", "K171771", "K252749", "K131580", "K182988", "K130255", "K193053", "K173909", "K182651", "K171861", "K200256", "K171537", "K160571", "K140654", "K200904", "K250073", "K121610", "K242911", "K151321", "K142448", "DEN130002", "K162822", "K180296", "K142595", "K220999" ], "registration_number": [ "3005529799", "3005333358", "9613069", "3003539867", "3006421415", "1319681", "3004529019", "3003422726", "8020316", "2250051", "3012963943", "2032682", "1319809", "3043149833", "2050012", "3002642396", "3016438761", "3043654757", "1000487132", "2027969", "2517506", "9614673", "9611444", "8031673", "2432235", "3002809144", "8023024", "2915274", "9680746", "3009448641", "3000308930", "1832816", "1319808", "9610126" ], "fei_number": [ "3005529799", "3002806809", "3005333358", "1000305840", "3006421415", "3002806559", "1000206808", "3004529019", "3003422726", "2250051", "3003559576", "3012963943", "1000136573", "3043149833", "2050012", "3002807423", "6387", "3002642396", "3016438761", "3043654757", "1000487132", "1000125596", "3003045237", "2517506", "3006769061", "3003952975", "2432235", "3002809144", "2915274", "1000305841", "3009448641", "2967", "3000308930", "1832816" ], "device_name": "Hemoglobin A1c Test System", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1373", "device_class": "2" } } ] }