{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194780", "product_res_number": "Z-1498-2022", "event_date_initiated": "2022-06-28", "event_date_created": "2022-08-04", "recall_status": "Open, Classified", "res_event_number": "90559", "product_code": "JIY", "k_numbers": [ "K991576" ], "product_description": "Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative\ndetermination of iron in human serum and (lithium heparin) plasma samples.", "code_info": "Unique Device Identification (UDI): 00630414596402\nAll lots", "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": "Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.", "root_cause_description": "Under Investigation by firm", "action": "Siemens issued Urgent Medical Device Correction (UMDC) Letter by FedEx beginning on 06/28/2022. Letter states reason for recall, health risk and action to take:\nFor customers operating with Atellica Software v.1.25.2 and lower, the resolution of this issue will be implemented in Atellica Software v1.25.3 which will be available soon. In the interim, please follow the instructions in the Additional Information section.\nCustomers who are operating with Atellica Software v1.26 will receive further information when a software update to resolve the issue is available.\nFor laboratories operating with Atellica Software v1.25.2 and below and Atellica Software v1.26 follow the workaround instructions in the Additional Information section until a future version of software is available.\nIf your laboratory has multiple Atellica CH 930 Analyzers, Siemens recommends testing the Atellica CH ALB_2 assay on a separate analyzer from the Iron_2 assay.\n\" If you choose not to separate the assays as indicated above, batch testing of Atellica CH ALB_2 may be considered.\n\" If Iron_2 and ALB_2 will be processed on the same Atellica CH analyzer, an RPC2 wash mitigation must be initiated after processing Iron_2 and prior to processing ALB_2.\nNote: Any of the following will initiate the RPC2 wash:\n\" After the Atellica CH 930 Analyzer has been in standby for 12 minutes.\n\" After completion of any Open Channel assay.\n\" Restarting the Atellica CH 930 Analyzer. Refer to the Atellica Solution Online Help for instructions on system restart\nPlease review this letter with your Medical Director. Perform the instructions provided in Additional Information. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support", "product_quantity": "1614 units US ; 7,979 units OUS", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, \nBR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, \nIE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, \nQA, KR, RO, RU, SA, RS, SG, SK, ZA, ES, SE, CH, TW, TH, TR, AE, UG, GB, UY, VA, VN.", "openfda": { "k_number": [ "K972363", "K890034", "K900902", "K902877", "K944462", "K833017", "K895249", "K852161", "K883792", "K881202", "K060264", "K831201", "K013097", "K051115", "K973933", "K841887", "K821184", "K890573", "K874918", "K910143", "K864882", "K863266", "K935287", "K782160", "K861652", "K863109", "K061793", "K845020", "K860478", "K943029", "K033983", "K781865", "K892838", "K902173", "K881104", "K851394", "K911170", "K030528", "K944911", "K841886", "K881167", "K935712", "K812840", "K812777", "K870986", "K800677", "K870144", "K843255", "K924691", "K964913", "K860799", "K874263", "K935176", "K901561", "K923565", "K930166", "K020816", "K961588", "K771838", "K884355", "K864819", "K890304", "K871284", "K880467", "K890395", "K892863", "K981241" ], "registration_number": [ "1319809", "3011989923", "3000308930", "8020316", "2050012", "3005146313", "3021841051", "3004192065", "9610529", "1063851", "3005094123", "9680746", "3005333358", "2250051", "3002642396", "2050010", "2517506", "3002809144", "2085064", "1319681", "3003795116", "9610126", "1827821", "3004493545", "3000148879", "9681753", "1181121", "3012963943", "3007662974", "3006198300", "2247288", "1616487", "1220972", "1832216", "3006716639", "8040374", "2432235" ], "fei_number": [ "3011989923", "1000305840", "3000308930", "5864", "2050012", "3005146313", "3002806560", "3021841051", "3004192065", "3005094123", "1000135102", "3000303338", "3005333358", "3002806809", "2250051", "3002642396", "2050010", "2517506", "3002809144", "3003795116", "1000136573", "1827821", "3004493545", "3000148879", "1181121", "1000206808", "3012963943", "3002806559", "3007662974", "3006198300", "1616487", "1220972", "1832216", "3006716639", "2432235", "1000442352", "1000122044" ], "device_name": "Photometric Method, Iron (Non-Heme)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1410", "device_class": "1" } } ] }