{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "120751", "product_res_number": "Z-0011-2014", "event_date_initiated": "2013-08-12", "event_date_posted": "2013-10-17", "recall_status": "Terminated", "event_date_terminated": "2015-11-18", "res_event_number": "65898", "product_code": "GKZ", "k_numbers": [ "K102644" ], "product_description": "ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter)\n\nThe ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.", "code_info": "All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide.", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "Elizabeth Bernasconi\n914-524-2495", "reason_for_recall": "Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.", "root_cause_description": "Software design", "action": "Siemens sent an Urgent Medical Device Correction Letter dated August 8, 2013, and Effectiveness Checks Forms were sent to customers on August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nCustomers were advised if they do not have an ADVIA Autoslide connected to their system, no action is required. To avoid the possibility of mislabeling a slide when an ADVIA 2120/2120i rack jam error occurs: Eject the sample rack. Troubleshoot and correct the reason for the rack jam error. Rerun the sample rack. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions.\n\nIf you need additional assistance, please contact Global Product Support\nTarrytown, New York @ osggps.hschematology.healthcare@siemens.com", "product_quantity": "311 units total (US: 51 units; Foreign: 260 units)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.", "openfda": { "k_number": [ "K960072", "K911626", "K160538", "K010765", "K021241", "K992849", "K942525", "K803219", "K091313", "K853304", "K922744", "K953498", "K162977", "K932530", "K030263", "K950918", "K844910", "K941171", "K030144", "K875346", "K945212", "K951459", "K871600", "K933475", "K982167", 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