{ "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": "118791", "product_res_number": "Z-0625-2014", "event_date_initiated": "2013-04-22", "event_date_posted": "2014-01-03", "recall_status": "Terminated", "event_date_terminated": "2014-02-12", "res_event_number": "65409", "product_code": "LCP", "k_numbers": [ "K011852" ], "product_description": "HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems.\r\n\r\nDimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.", "code_info": "Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13.", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 Gbc Dr Ms 514", "address_2": "PO BOX 6101", "city": "Newark", "state": "DE", "postal_code": "19702-2466", "additional_info_contact": "Customer Support\n800-441-9250", "reason_for_recall": "Positive bias on the lots listed compared to alternate methods and a higher frequency of \"Above Assay Range\" flags with the lots listed.", "root_cause_description": "Process control", "action": "Siemens sent an Urgent Medical Device Recall letter in April 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discard any remaining inventory of the affected product. Siemens will replace any unused inventory at no charge. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate they have received the information. Customers were asked to retain the letter with their laboratory records and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative.\r\nFor questions regarding this recall call 1-800-441-9250.", "product_quantity": "11006 Total", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.", "openfda": { "k_number": [ "K842689", "K780573", "K972265", "K971919", "K121492", "K984529", "K823869", "K811000", "K050574", "K030553", "K962597", "K023654", "K130014", "K920397", "K102510", "K942009", "K952337", "K935613", "K060650", "K780819", "K834294", "K832775", "K895661", "K940971", "K791103", "K140801", "K011852", "K003280", "K983726", "K871679", "K882051", "K070819", "K031043", "K811710", "K900718", "K072714", "K912748", "K130860", "K951361", "K122472", "K033674", "K811567", "K990992", "K800857", "K871388", "K022661", "K053411", "K941616", "K042459", "K110934", "K192987", "K801422", "K802721", "K992921", "K781948", "K021897", 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