{ "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": 2 } }, "results": [ { "cfres_id": "193580", "product_res_number": "Z-1252-2022", "event_date_initiated": "2022-04-13", "event_date_created": "2022-06-09", "recall_status": "Open, Classified", "res_event_number": "90153", "product_code": "JLW", "k_numbers": [ "K151792" ], "product_description": "Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.\nSiemens Material Number (SMN):\t11066001", "code_info": "UDI: 00630414007960\n\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": "Lots incompatible with Test Definition (TDef) Version 1.4,\npotentially lead to the generation of erroneous total T3 results", "root_cause_description": "Under Investigation by firm", "action": "Siemens issued an Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 04/13/2022 and an Urgent Field Safety Notice (UFSN) was issued to all OUS. Letter states reason for recall, health risk and action to take:\nIf your facility has multiple lots of T3 available for use and some kit lots are below lots ending in 244, follow the steps below to ensure that T3 results will be correct for all available lots until all kit lots available for use are kit lots ending in 244 or above.\n Ensure that all IM modules connected to an Atellica Solution have only 1 lot of T3 reagent (all IM modules have the same lot of T3 reagent packs) loaded onto every IM.\nFor reagent kit lots below lots ending in 244:\nRescan the Master Curve Card (MCC) for the T3 reagent lot that is on the Atellica IM\nbefore processing with that reagent lot, following instructions in the Atellica Online Help\n(SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D\nBarcodes ).\nNote: If the IM is rebooted while using kit lots below lots ending in 244, the MCC will need to be re-scanned before samples are processed.\n For reagent lots ending in 244 and above:\nRescan the Master Curve Card (MCC) for the T3 reagent kit lot that is on the Atellica IM,\nfollowing instructions in the Atellica Online Help (SMN 11313586, section Scanning IM\nMaster Curves and Assay Test Definitions 2D Barcodes .\nReboot all IM modules connected to Atellica Solution following instructions in the Atellica Online Help (SMN 11313586, section titled Shutting Down and Powering Off Analyzers within the System ) when changing from reagent kit lots below lots ending in 244 to a reagent pack associated with kit lots ending in 244 or above before processing with that reagent kit lot.\nPlease review this letter with your Medical Director.\nComplete and return the Field Action Effectiveness Check Form attached to this letter within 30 days.", "product_quantity": "1,566", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, \nRussian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.", "openfda": { "k_number": [ "K023093", "K791065", "K251543", "K792562", "K852438", "K042281", "K800798", "K991146", "K943195", "K822291", "K072458", "K171103", "K950921", "K912852", "K961629", "K981312", "K830928", "K802467", "K781170", "K921700", "K921816", "K820089", "K831972", "K980574", "K896867", "K872897", "K952211", "K925132", "K083173", "K130469", "K011527", "K243570", "K900014", "K871505", "K772192", "K930050", "K961491", "K760801", "K060090", "K792443", "K221225", "K013420", "K962216", "K830036", "K925637", "K960195", "K842593", "K843545", "K833713", "K935049", "K881627", "K771234", "K234091", "K872305", "K811431", "K903725", "K870245", "K003752", 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Thyroid-Stimulating Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1690", "device_class": "2" } } ] }