{ "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": "140899", "product_res_number": "Z-0340-2016", "event_date_initiated": "2015-09-24", "event_date_posted": "2015-11-25", "recall_status": "Terminated", "event_date_terminated": "2017-01-13", "res_event_number": "72392", "product_code": "LCP", "k_numbers": [ "K110934" ], "product_description": "ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.", "code_info": "10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591)", "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": "800-441-9250", "reason_for_recall": "Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias.", "root_cause_description": "Under Investigation by firm", "action": "Siemens has issued an Urgent Medical Device Recall in the US and an Urgent Field Safety Notice Outside the US on September 24, 2015, instructing customers to discontinue use, discard reagent and request no charge replacement kits for these products.", "product_quantity": "3031", "distribution_pattern": "Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada.", "openfda": { "k_number": [ "K041635", "K896582", "K993131", "K801422", "K851636", "K033674", "K893224", "K896334", "K790046", "K792086", "K231465", "K160762", "K072686", "K791428", "K142789", "K896335", "K102914", "K882051", "K042193", "K810714", "K942009", "K810638", "K991483", "K912748", "K080618", "K893453", "K140829", "K120497", "K020235", "K983726", "K861697", "K023654", "K110188", "K031042", "K010748", "K791103", "K071132", "K140827", "K133344", "K941616", 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