{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167736", "product_res_number": "Z-0601-2019", "event_date_initiated": "2018-10-05", "event_date_created": "2018-12-13", "recall_status": "Terminated", "event_date_terminated": "2020-06-16", "res_event_number": "81188", "product_code": "LCP", "k_numbers": [ "K021484" ], "product_description": "Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.", "code_info": "Lot 7055", "firm_fei_number": "3005529799", "recalling_firm": "Tosoh Bioscience Inc", "address_1": "3600 Gantz Rd", "city": "Grove City", "state": "OH", "postal_code": "43123-1895", "additional_info_contact": "Ms. Bernadette O'Connell\n800-248-6764", "reason_for_recall": "Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.", "root_cause_description": "Device Design", "action": "The firm sent notification to consignees on October 5, 2018, via Urgent Medical Device Recall letter. The letter informed consignees of the potential degradation of HbA1c control lot 7055 prior to the 60-days product stability claim.\n\nImmediate Actions to be taken by the Customer\n\" Review the content of this letter with your laboratory staff.\n\" Inform laboratory staff to avoid storing the control material in direct exposure to light.\n\" Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days\nof receiving this notification.\n\" In the event of an early degradation of the control material, new controls should be used to verify the\ninstrument performance prior to use.\n\" Maintain this notification with your laboratory records and forward this information to others in your\nlaboratory.\n\" If you have obtained unexpected test results, delays in test result reporting, or received any\ncomplaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh\nTechnical Support 24 hours a day, seven days a week at (800) 248-6764.\n\" Should you have any questions regarding this medical device recall, please feel free to contact\nBernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be\navailable to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).", "product_quantity": "1000", "distribution_pattern": "Distributed nationwide. Foreign distribution to Canada.", "openfda": { "k_number": [ "K071466", "K823869", "K063306", "K062658", "K183230", "K833772", "K800857", "K993131", "K873428", "K090413", "K050178", "K935613", "K941616", "K920449", "K993590", "K990899", "K023654", "K930823", "K934070", "K063643", "K013465", "K904027", "K880673", "K872852", "K011434", "K926469", "K980888", "K130990", "K781851", "K921676", "K093548", "K801561", "K936204", "K921305", "K991246", "K821360", "K091400", "K802432", "K110188", "K142789", "K791365", "K022661", "K072714", "K992085", "K891235", "K940971", "K080618", "K912748", "K920820", "K973696", "K983172", "K905709", "K170623", "K984268", "K882051", "K120199", "K020235", "K893453", "K882222", "K832775", "K983253", "K791642", "K884184", "K170147", "K895661", "K072686", "K051321", "K063400", "K140827", "K081269", "K070734", "K820279", "K971919", "K834294", "K031539", "K896830", "K041444", "K904814", "K000885", "K955087", "K100547", "K931183", "K162281", "K896335", "K041635", "K984529", "K780573", "K983726", "K833805", "K000887", "K802233", "K940143", "K073309", "K946274", "K033847", "K130014", "K142664", "K231465", "K901414", "K042459", "K831837", "K871679", "K862371", "K952337", "K832087", "K791135", "K180509", "K791777", "K192987", "K042193", "K961674", "K060001", "K791103", "K021897", "K921831", "K881863", "K801289", "K031380", "K081895", "K111128", "K790583", "K861697", "K141944", "K920198", "K041764", "K991850", "K936285", "K925204", "K780819", "K121842", "K803186", "K990992", "K902457", "K896334", "K001392", "K221326", "K090699", "K052464", "K791428", "K852986", "K781948", "K163633", "K896582", "K893224", "K060650", "K070452", "K792086", "K110313", "K110056", "K003280", "K884315", "K130860", "K811710", "K181915", "K913614", "K161533", "K811000", "K911625", "K031043", "K802721", "K113437", "K852111", "K121366", "K942009", "K864643", "K992921", "K842689", "K012525", "K880698", "K010748", "K102045", "K122101", "K140801", "K112015", "K820076", "K070819", "K831478", "K790046", "K023763", "K991483", "K973365", "K012410", "K875354", "K141750", "K800794", "K100304", "K811567", "K962597", "K830935", "K050574", "K082275", "K020532", "K020234", "K131307", "K900718", "K011933", "K120497", "K854010", "K810638", "K994045", "K951361", "K063209", "K972265", "K871388", "K874749", "K851636", "K040872", "K171650", "K133344", "K801422", "K905513", "K214117", "K833356", "K151809", "K974491", "K091711", "K003120", "K812242", "K122472", "K860572", "K121492", "K160762", "K192369", "K822867", "K031042", "K011852", "K133803", "K031296", "K902455", "K140829", "K802832", "K102510", "K030553", "K173127", "K102914", "K933287", "K000239", "K862556", "K963844", "K822977", "K810958", "K051200", "K033674", "K071132", "K810714", "K920397", "K110934", "K053411", "K021484" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2", "registration_number": [ "3002637618", "3003460426", "1181121", "1717966", "2032900", "8043889", "3004111573", "3023949424", "3007662974", "2432235", "9610633", "3005146313", "3009448641", "2050012", "2027969", "3016438761", "1220972", "2050010", "3012526002", "3043149833", "8023024", "3011061417", "8031673", "1832816", "3004529019", "3013660430", "9613069", "3003917514", "3003539867", "3014607865", "3017548799", "9610126", "3006421415", "3032069621", "8023060", "3002809144", "1423455", "3010825766", "2084025", "2915274", "3008178161", "3006198300", "1219029", "3004145393", "3035708936", "3015525148", "1832216", "9610529", "3004493545", "2030861", "2247288", "9611444", "3043654757", "3003795116", "3023162659", "1827821", "1931251", "1616487", "8020316", "3003422726", "3005333358", "9680746", "1000487132", "2085064", "2517506", "3005529799" ], "fei_number": [ "3002637618", "3003460426", "3003992026", "1181121", "1717966", "3000206414", "3023949424", "3004111573", "3007662974", "2432235", "3002807423", "3005146313", "3009448641", "2050012", "3002806560", "3016438761", "1220972", "3000215862", "2050010", "1000122044", "3012526002", "3043149833", "3011061417", "3002806693", "2967", "3003045237", "1832816", "3004529019", "3013660430", "1000135102", "3002806809", "3004445302", "3014607865", "3003917514", "3017548799", "3006769061", "3006421415", "3032069621", "3002809144", "3010825766", "2084025", "3002698769", "6387", "3008178161", "3006198300", "1219029", "3004145393", "2915274", "3035708936", "1832216", "3004493545", "3003206796", "3002806559", "3043654757", "3003795116", "1000125596", "3023162659", "1827821", "1931251", "1616487", "3003422726", "3005333358", "1000206808", "1000487132", "2517506", "3005529799" ] } } ] }