{ "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": "121482", "product_res_number": "Z-0136-2014", "event_date_initiated": "2013-08-26", "event_date_posted": "2013-11-02", "recall_status": "Terminated", "event_date_terminated": "2014-01-14", "res_event_number": "66101", "product_code": "LCP", "k_numbers": [ "K090413" ], "product_description": "Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by \r\nBayer HealthCare LLC, Sunnyvale, CA \r\n\r\n\r\nThe A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.", "code_info": "Lot: 1300733 (US, China);  Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan)", "firm_fei_number": "3000206585", "recalling_firm": "Bayer Healthcare Llc", "address_1": "510 Oakmead Pkwy", "city": "Sunnyvale", "state": "CA", "postal_code": "94085-4022", "additional_info_contact": "Roger Sonnenburg,\n408-524-2255 Ext. 290", "reason_for_recall": "Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release.", "root_cause_description": "Nonconforming Material/Component", "action": "Bayer Healthcare sent an Urgent Medical Device Recall letter dated August 26, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and quarantine any affected product. Complete the attached Recall Response Form and fax to Bayer Customer Service. Customers were instructed to use the attached letter to notify affected next level customers of the recall. For questions regarding this recall call 408-524-2255, ext 290.", "product_quantity": "138 Kits in US (Total 2452)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to China, Argentina, Uruguay, Japan.", "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", "K063306", "K063400", "K896830", "K991850", "K983253", "K050178", "K110056", "K071132", "K173127", "K896582", "K820076", "K010748", "K110313", "K802233", "K051200", "K791642", "K852986", "K905513", "K934070", "K081269", "K920449", "K070452", "K874749", "K791135", "K936204", "K791777", "K993131", "K020234", "K931183", "K830935", "K904027", "K091400", "K060001", "K151809", "K120497", "K991246", "K901414", "K033847", "K810714", "K822977", "K881863", "K833805", "K991483", "K133803", "K113437", "K000885", "K930823", "K791365", "K140827", "K071466", "K141944", "K955087", "K141750", "K790046", "K023763", "K090413", "K875354", "K031539", "K992085", "K073309", "K973696", "K000887", "K862556", "K821360", "K880673", "K192369", "K013465", "K833772", "K854010", "K100547", "K100304", "K802432", "K801561", "K781851", "K042193", "K801289", "K936285", "K921831", "K011933", "K041764", "K080618", "K896334", "K001392", "K111128", "K031296", "K822867", "K911625", "K110188", "K040872", "K974491", "K121842", "K902455", "K862371", "K810638", "K872852", "K961674", "K921676", "K130990", "K896335", "K880698", "K020532", "K800794", "K041635", "K140829", "K802832", "K921305", "K020235", "K102045", "K231465", "K093548", "K864643", "K904814", "K021484", "K052464", "K983172", "K882222", "K833356", "K131307", "K820279", "K831837", "K791428", "K933287", "K984268", "K884315", "K091711", "K891235", "K893453", "K063209", "K940143", "K181915", "K920198", "K812242", "K072686", "K160762", "K012410", "K860572", "K926469", "K051321", "K973365", "K913614", "K946274", "K120199", "K012525", "K810958", "K803186", "K993590", "K831478", "K031042", "K090699", "K873428", "K082275", "K112015", "K162281", "K851636", "K214117", "K990899", "K003120", "K121366", "K161533", "K170623", "K070734", "K920820", "K142664", "K925204", "K170147", "K000239", "K792086", "K171650", "K081895", "K062658", "K063643", "K183230", "K861697", "K180509", "K133344", "K011434", "K963844", "K122101", "K994045", "K905709", "K163633", "K142789", "K832087", "K980888", "K041444", "K221326", "K102914", "K031380", "K790583", "K852111", "K893224", "K902457" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2", "registration_number": [ "2027969", "2432235", "8031673", "1219029", "3043149833", "1220972", "9610633", "2050012", "8023060", "3005529799", "2032900", "3013660430", "1827821", "1931251", "3011061417", "3002809144", "8043889", "2084025", "3006198300", "8023024", "2915274", "1616487", "3002637618", "3004111573", "3003539867", "3014607865", "9610126", "3007662974", "2085064", "3009448641", "1181121", "9613069", "3035708936", "3012526002", "9680746", "3015525148", "3004145393", "3023162659", "2517506", "3004529019", "3017548799", "2247288", "3016438761", "3005146313", "3003460426", "3032069621", "1832216", "3023949424", "3003422726", "3005333358", "2050010", "1423455", "1717966", "3008178161", "2030861", "9611444", "8020316", "9610529", "3003917514", "3004493545", "3010825766", "3003795116", "1832816", "3043654757", "3006421415", "1000487132" ], "fei_number": [ "3003992026", "2432235", "1219029", "3043149833", "3002806559", "1220972", "1000206808", "3002806809", "2050012", "3005529799", "2084025", "3013660430", "1827821", "1931251", "3011061417", "3002809144", "3006198300", "3000215862", "6387", "2915274", "3003045237", "3002637618", "1616487", "3004111573", "3014607865", "3007662974", "3002806560", "3009448641", "1000135102", "1181121", "3035708936", "3012526002", "3004145393", "3000206414", "3023162659", "3004445302", "2517506", "3002806693", "3017548799", "3004529019", "3016438761", "3005146313", "3003460426", "3002698769", "3032069621", "1832216", "3003206796", "3023949424", "3003422726", "1000122044", "2967", "3005333358", "1000125596", "2050010", "1717966", "3008178161", "3004493545", "3006769061", "3003917514", "3010825766", "3003795116", "1832816", "3002807423", "3043654757", "3006421415", "1000487132" ] } } ] }