{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210823", "product_res_number": "Z-0496-2025", "event_date_initiated": "2024-10-21", "event_date_posted": "2024-11-20", "recall_status": "Open, Classified", "res_event_number": "95626", "product_code": "JJE", "k_numbers": [ "K161954" ], "product_description": "Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step.\nSiemens Material Number(SMN): 11099326\n\nAll lots starting with N15 or 15 are expected to have the defect.", "code_info": "Lot #\t\t\t\t\t\t\t\tUDI\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\nN1527024\t\t\t\t\t\t\t(01)00630414596143(10)N1527024(17)20291002;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\nN1526424\t\t\t\t\t\t\t(01)00630414596143(10)N1526424(17)20291001;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\nN1525924\t\t\t\t\t\t\t(01)00630414596143(10)N1525924(17)20290924\t;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\nN1525324\t\t\t\t\t\t(01)00630414596143(10)N1525324(17)20290918\t;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\nN1524224\t\t\t\t\t\t(01)00630414596143(10)N1524224(17)20290911;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1523724\t\t\t\t\t\t(01)00630414596143(10)N1523724(17)20290904;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1523024\t\t\t\t\t\t(01)00630414596143(10)N1523024(17)20290827;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1521824\t\t\t\t\t\t(01)00630414596143(10)N1521824(17)20290814;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1521424\t\t\t\t\t\t(01)00630414596143(10)N1521424(17)20290808;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1519324\t\t\t\t\t\t(01)00630414596143(10)N1519324(17)20290719;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1518924\t\t\t\t\t\t(01)00630414596143(10)N1518924(17)20290716;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1518224\t\t\t\t\t\t(01)00630414596143(10)N1518224(17)20290710;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1518324\t\t\t\t\t\t(01)00630414596143(10)N1518324(17)20290710;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1516224\t\t\t\t\t\t(01)00630414596143(10)N1516224(17)20290621;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1515624\t\t\t\t\t\t(01)00630414596143(10)N1515624(17)20290612;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1514924\t\t\t\t\t\t(01)00630414596143(10)N1514924(17)20290605;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1514124\t\t\t\t\t\t(01)00630414596143(10)N1514124(17)20290530;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1513324\t\t\t\t\t\t(01)00630414596143(10)N1513324(17)20290522;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1512824\t\t\t\t\t\t(01)00630414596143(10)N1512824(17)20290515;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1512424\t\t\t\t\t\t(01)00630414596143(10)N1512424(17)20290510;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1511224\t\t\t\t\t\t(01)00630414596143(10)N1511224(17)20290506;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1510724\t\t\t\t\t\t(01)00630414596143(10)N1510724(17)20290423;\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\nN1510124\t\t\t\t\t\t(01)00630414596143(10)N1510124(17)20290419.", "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": "A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for\nseven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine\nKinase (CK), Cystatin C, and Salicylate.", "root_cause_description": "Under Investigation by firm", "action": "Siemens issued Urgent Medical Device Correction (UMDC) to l US affected customers\nvia FedEx beginning on 10/21/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers beginning on 10/21/2024. \nIn accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities. \nLetter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. \n Review your current Atellica CH Reaction Ring Cuvette Segment stock. All Atellica CH\nReaction Ring Cuvette Segments beginning with 11 are not part of this communication\nand can be used without restriction. Any other lot in your stock must be immediately\ndiscarded.\n Locate your analyzer s serial number within the Appendix B Serial Number List. If your\nanalyzer s serial number is in the provided list, perform the instructions in Appendix A to\nassess, inspect, and/or replace the Atellica CH Reaction Ring Cuvettes Segments.\n Determine your laboratory s replacement needs and provide detailed information to\nSiemens Healthineers for reporting to authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days.\n Please retain this letter with your laboratory records and forward this letter to those who may have received this product.\n\nSiemens Healthineers has confirmed Atellica CH reaction ring segments beginning with lot number 11 are not impacted, and going forward all future lots will work as expected. \nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.", "product_quantity": "9729 units", "distribution_pattern": "US Nationwide and Worldwide distribution:\nForeign:\nAlgeria\nAlgeria\nArgentina\nAustralia\nAustria\nBahrain\nBangladesh\nBelgium\nBrazil\nBulgaria\nBurkina Faso\nCanada\nChile\nChina\nColombia\nCongo, Republic\nC¿te dIvoire\nCroatia\nCyprus\nCzech Republic\nDenmark\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nGermany\nGreece\nHong Kong\nHungary\nIndia\nIran, Islamic Republic of\nIraq\nIreland\nIsrael\nItaly\nJapan\nJordan\nKenya\nKuwait\nLatvia\nLibya\nMalaysia\nMexico\nMoldova, Rep. of\nMorocco\nNepal\nNetherlands\nNorway\nOman\nPakistan\nParaguay\nPeru\nPhilippines\nPoland\nPortugal\nQatar\nRepublic Korea\nRomania\nRussian Federation\nSaudi Arabia\nSerbia\nSingapore\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTaiwan, Province of China\nThailand\nTunisia\nTurkey\nUganda\nUkraine\nUnited Arab Emirates\nUnited Kingdom Great Britain\nUruguay\nVatikancity\nVietnam", "openfda": { "k_number": [ "K873130", "K971761", "K882081", "K802609", "K840501", "K882559", "K861055", "K780083", "K840129", "K772319", "K841916", "K831649", "K930489", "K863531", "K830762", "K860647", "K883209", "K953239", "K802835", "K965240", "K945271", "K110035", "K042169", "K073370", "K970227", "K813160", "K926060", "K842500", "K823386", "K002982", "K832648", "K800053", "K853003", "K931744", "K843283", "K800572", "K950353", "K924084", "K843059", "K844114", 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"1220972", "3042244350", "3002806809", "3000303338", "3017098905", "1827821", "3002608770", "3003402518", "3010031137", "3000215862", "3003413192", "2431530", "3005748564", "3014607865", "3002485711", "3004185580", "3009473156", "1000455123", "3002806560", "3003542872", "3012526002", "3003741796", "1000136573", "3003637681", "3016438761", "1000305841", "1217183", "2915796", "3010324880", "3000148879", "1717966", "3003917514", "3002808382", "3016244760", "3002807876", "1000186023", "3033967997" ], "device_name": "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2160", "device_class": "1" } } ] }