{ "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": "114906", "product_res_number": "Z-0647-2013", "event_date_initiated": "2012-11-28", "event_date_posted": "2013-01-07", "recall_status": "Terminated", "event_date_terminated": "2013-10-28", "res_event_number": "63852", "product_code": "JLW", "k_numbers": [ "K872305" ], "product_description": "Immunoradiometric assay.", "code_info": "Lots 831 and 832", "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": "914-524-2955", "reason_for_recall": "The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)", "root_cause_description": "Nonconforming Material/Component", "action": "Siemens sent an Urgent Medical Device Recall letter dated November 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, complete and return the Urgent Medical Device Recall Effectiveness Check form included with the letter by fax to 302-631-7597. Customers were also instructed to determine their replacements needed, and to forward the recall letter to whomever they may have distributed the affected product. For questions customers were instructed to contact their Siemens Technical Solutions Ceter or their local technical support representative. \nFor questions regarding this recalla call 914-524-2955.", "product_quantity": "Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)", "distribution_pattern": "Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico.\n\nInternationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,", "openfda": { "k_number": [ "K870244", "K013420", "K900277", "K130469", "K870320", "K864677", "K912324", "K843540", "K871505", "K962216", "K970393", "K843395", "K864079", "K942661", "K160541", "K942566", "K822935", "K001606", "K042281", "K983442", "K862407", "K854087", "K990658", "K885157", "K874622", "K770915", "K920856", "K791301", "K251543", "K881443", "K870904", "K083844", "K861918", "K881627", "K083173", "K925132", "K822827", "K897138", 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