{ "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": "183848", "product_res_number": "Z-0101-2021", "event_date_initiated": "2020-09-22", "event_date_posted": "2020-10-13", "recall_status": "Open, Classified", "res_event_number": "86504", "product_code": "JIT", "k_numbers": [ "K131307" ], "product_description": "ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems\nSiemens Material Number (SMN): 10361941", "code_info": "All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630", "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": "Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.", "root_cause_description": "Device Design", "action": "Siemens Urgent Medical Device Recall (ACHC20-18.A.US.CHC) distributed to customers on 9/22/20, in the United States and an Urgent Field Safety Notice (ACHC20-18.A.OUS.CHC) was distributed to customers outside the United States who have received ADVIA Chemistry Fructosamine in-date reagent lots.\nFor Atellica, an Urgent Medical Device Recall (ACHC20-18.A.US) was distributed to l customers in the United States and an Urgent Field Safety Notice (ACHC20-1.OUS) was distributed to all customers outside the United States who have received Atellica CH in date reagent lots.\nThese letters instruct the customers to:\nPerform the following actions on the ADVIA Chemistry System\n1. Enter the Real-time correction factor in the Analytical Parameters (Chemistry) window.\n2. Once the Real-time correction factor has been configured, update QC ranges as described above in the FRUC \n QC Definition following your laboratory procedures.\n3. Update the reference range following your laboratory procedures.\n4. Perform a FRUC calibration and process QC.\n5. Perform a system back-up.\nComplete and return the Field Correction Effectiveness Check attached to this letter within 30 days.\n\" Review this letter with your Medical Director.\n\" If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative", "product_quantity": "US: 23 units; OUS: 204 units", "distribution_pattern": "CA, DE, MD, NC, NJ, NY, PA \n\nForeign:\nArgentina¿¿¿¿¿¿\nAustralia¿¿¿¿¿¿\nBrazil¿¿¿¿\nCanada¿¿¿¿¿\nCzech¿Republic¿\nDenmark¿¿¿¿¿¿¿¿\nGermany¿¿¿¿¿¿¿¿\nItaly¿¿¿¿¿¿¿¿¿¿\nNetherlands¿¿¿¿\nP.R.¿China¿¿¿¿¿\nParaguay¿¿¿¿¿¿¿\nSlovakia¿¿¿¿¿¿¿\nTurkey¿¿¿¿¿¿¿¿¿\nUnited¿Kingdom¿\nVietnam¿¿¿¿¿¿¿¿", "openfda": { "k_number": [ "K142181", "K093357", "K061751", "K823023", "K163534", "K843112", "K872263", "K895649", "K913371", "K053291", "K994291", "K792290", "K991705", "K800220", "K061702", 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"device_class": "2" } } ] }