{ "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": "130530", "product_res_number": "Z-0420-2015", "event_date_initiated": "2014-09-30", "event_date_posted": "2014-11-21", "recall_status": "Terminated", "event_date_terminated": "2015-08-10", "res_event_number": "69434", "product_code": "LCP", "k_numbers": [ "K102045", "K102510" ], "product_description": "Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension 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": "Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA\t13308BA 13329AA\t13350AA 14006AA\t14041BA 14069BB\t14083BA   Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266\tBA4273\tBA4280 BA4287\tGA4301\tGA4315 GC4322\tGA4343\tGA4350 GA4357\tGA5013\tGA5020", "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": "Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.", "root_cause_description": "Nonconforming Material/Component", "action": "Siemens sent an Urgent Medical Device Correction letter dated September 2014 was provided to all Dimension Vista HbA1c and Dimension HB1C customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discontinue use of and discard the affected devices.\nCustomers need to review the letter with their Medical Director. Siemens will replace any unused inventoryof the affected lots at no charge. Customers were asked to complete the attached form and fax it to 302-631-7795. Customers should retain a copy of the letter with their laboratory records, and forward the letter to those who may have received this product. Customers with questions should contact their Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative.\nFor questions regarding this recall call 800-441-9250.", "product_quantity": "53, 046", "distribution_pattern": "Worldwide Distribution: US (nationwide) and internationally to: Canada.", "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", "K884184", 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"1000487132" ] } } ] }