{ "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": "166372", "product_res_number": "Z-0190-2019", "event_date_initiated": "2018-06-29", "event_date_created": "2018-10-18", "recall_status": "Terminated", "event_date_terminated": "2021-08-12", "res_event_number": "80774", "product_code": "JJE", "k_numbers": [ "K161954" ], "product_description": "Atellica Sample Handler Connect (SMN 11069018).\nThe Atellica\" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.", "code_info": "Software (SW) version 1.13 and lower", "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": "Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified:\n1.\tReagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time.\n2.\tSample barcodes may be incorrectly read\n3.\tThe Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. \n4.\tThe Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed.\n5.\tThe Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.", "root_cause_description": "Software design", "action": "Siemens issued an Urgent medical Device Correction, (UMDC ASW18-02.A.US) and Urgent Field Safety Notification (UFSN ASW18-02.A.OUS) on 6/29/18, via FedEx to the US Customer and via email distribution to countries Outside US (OUS).\nThe field action letters explain the behaviors and informed Customers of action to be taken to prevent the behaviors from occurring. Siemens has released an updated software (SW) version (V), 1.14, which corrects the reported behaviors.", "product_quantity": "35", "distribution_pattern": "Nationwide\nForeign:\nAustralia\nAustria\nBelgium\nBrazil\nCanada\nCroatia\nCzech Republic\nDenmark\nFrance\nGermany\nGreece\nItaly\nJapan\nMalaysia\nMexico\nNetherlands\nNorway\nPoland\nRepublic Korea\nSingapore\nSpain\nSweden\nSwitzerland\nU.A.E.\nUnited Kingdom", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", "K890927", "K841916", "K854243", "K771345", "K872105", "K962235", "K883533", "K781076", "K915366", "K854936", "K823386", "K840129", "K943493", "K942443", "K961274", 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