{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142132", "product_res_number": "Z-0468-2016", "event_date_initiated": "2015-11-19", "event_date_posted": "2015-12-22", "recall_status": "Terminated", "event_date_terminated": "2017-08-15", "res_event_number": "72752", "product_code": "GGP", "k_numbers": [ "K884544" ], "product_description": "Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency", "code_info": "Lot Number 44637, exp. 2016-11-30", "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": "Ms. Elizabeth Bernasconi\n914-524-2495", "reason_for_recall": "Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.", "root_cause_description": "Employee error", "action": "Siemens sent an Urgent Medical Device Correction Letter dated November 19, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer.\n\nActions to be Taken by Customers: \n\n If you are using the affected lot of Factor VIII Chromogenic Assay on a Sysmex CA-1500 or CA-7000 System, please discontinue use. - Due to a different detection principle, the use on BCS and BCS XP is not affected and you can continue using the product on BCS / BCS XP. - Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. - Review your inventory of this product to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Corrective Action: The Factor VIII Chromogenic Assay Lot Number 44637 kits were placed on product hold on August 19, 2015, at the Siemens Distribution Centers. For further questions, please call ( 914) 524 - 2495.", "product_quantity": "Domestic: 52 kits, Foreign: 623 kits", "distribution_pattern": "Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.", "openfda": { "k_number": [ "K000649", "K792656", "K981200", "K820085", "K843215", "K200033", "K220728", "K790423", "K903468", "K897136", "K974711", "K050448", "K971985", "K941752", "K952666", "K961929", "K092170", "K002541", "K854312", "K872941", "K033631", "K050365", "K980875", "K945414", "K972342", "K062530", "K983898", "K983914", "K896174", "K882603", "K043571", "K012386", "K843438", "K870917", "K872479", "K812975", "K761058", "K861475", "K223402", "K914818", "K881037", "K934584", "K952669", "K013168", "K980885", "K052825", "K992704", "K791794", "K834050", "K022290", "K840927", "K924425", "K841461", "K843451", "K861049", "K952126", "K841957", "K902566", "K870353", "K924884", "K063323", "K962968", "K962489", "K915163", "K002467", "K840114", "K972288", "K983107", "K890409", "K912711", "K011424", "K963106", "K884797", "K843310", "K053499", "K960438", "K964459", "K042576", "K853461", "K832372", "K834051", "K951640", "K900395", "K193204", "K832114", "K002350", "K870354", "K884544", "K864480", "K861079", "K902528", "K972482", "K823453", "K912468", "K943225", "K882602", "K884941", "K973143", "K955738", "K792507", "K884551", "K840329", "K954017", "K922782", "K874940", "K841708", "K000398", "K934314", "K834031", "K861417", "K082631", "K964270", "K892859", "K950015", "K802356", "K954040", "K183440", "K040987", "K840928", "K230852", "K871039", "K972005", "K062430", "K900397", "K040843", "K010379", "K070635", "K972116", "K934210", "K214002", "K821963", "K861217", "K920012", "K833892", "K914307", "K981038", "K922201", "K023990", "K051054", "K792476", "K993553", "K952668", "K931906", "K181525", "K920981", "K904247", "K981696", "K010963", "K013492", "K032139", "K854014", "K102164", "K921449", "K962825", "K942087", "K842617", "K792508", "K900399", "K884058", "K853462", "K890634", "K792335", "K864701", "K864497", "K251440", "K082205", "K912025", "K864481", "K133005", "K930327", "K971519", "K900398", "K930235", "K884940", "K925617", "K792475", "K884881", "K860371", "K861159", "K792511", "K861048", "K874097", "K841364", "K981817", "K812974", "K792336", "K823267", "K913424", "K812431", "K861216" ], "device_name": "Test, Qualitative And Quantitative Factor Deficiency", "medical_specialty_description": "Hematology", "regulation_number": "864.7290", "device_class": "2", "registration_number": [ "1721937", "3003691680", "9710666", "2431530", "3037000637", "8043599", "2183608", "3004075036", "2245451", "9610746", "3008386529", "1618982", "3004737529", "3003601075", "9610806", "2432235", "1217183", "3004434070", "1835316", "3003485232", "2518152" ], "fei_number": [ "3003565434", "3003691680", "2431530", "3001644026", "3037000637", "2183608", "1000117401", "3004075036", "2245451", "3008386529", "1618982", "3004737529", "3002806557", "3003601075", "3000210416", "2432235", "1217183", "3005917516", "3004434070", "3003485232", "2518152" ] } } ] }