{ "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": "40371", "product_res_number": "Z-0171-06", "event_date_initiated": "2005-05-20", "event_date_posted": "2005-11-18", "recall_status": "Terminated", "event_date_terminated": "2012-05-03", "res_event_number": "32571", "product_code": "LCP", "k_numbers": [ "K041635" ], "product_description": "Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''", "code_info": "Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.", "firm_fei_number": "3004950843", "recalling_firm": "Provalis Diagnostics", "address_1": "7380 W Sand Lake Rd Ste 500 7380 W Sand Lake Rd", "address_2": "Ste 500", "city": "Orlando", "state": "FL", "postal_code": "32819-5257", "reason_for_recall": "Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.", "root_cause_description": "Other", "action": "All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.", "product_quantity": "838 Kits of 10 test devices each", "distribution_pattern": "Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.", "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" ] } } ] }