{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150149", "product_res_number": "Z-0395-2017", "event_date_initiated": "2016-10-04", "event_date_posted": "2016-11-11", "recall_status": "Terminated", "event_date_terminated": "2017-06-05", "res_event_number": "75366", "product_code": "LCP", "k_numbers": [ "K072714" ], "product_description": "Tina-Quant Hemoglobin A1c Gen. 2\nHemoglobin A1c test\nCatalog number 04528123190 / 05401640190", "code_info": "Not applicable", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Roche Support Network Customer Support C\n800-428-2336", "reason_for_recall": "Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual\nTina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles.\nThis issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected.\nThe issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected,\nan erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation\n(introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can\nfurther lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue,\nrelevant medical risk for the patient cannot entirely be excluded.", "root_cause_description": "Storage", "action": "On 10/4/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Direct Consignees and Distributors via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. \n\nDirect Consignee\nActions Required\n\" Follow the instructions in the Customer Actions for Prevention/Detection of the Issue section of this Urgent Medical Device Correction (UMDC).\n\" Complete the attached fax form (7184-00-1016) and fax it to 1-844-294-7181.\n\" File this Urgent Medical Device Correction (UMDC) for future reference.\nQuestions\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week\nat 1-800-428-2336 if you have questions about the information contained in this UMDC.\n\nDistributor\nActions Required\n\" Ensure proper storage conditions (2-8C) are maintained for the reagents listed in the table above,\nper their respective method sheet.\n\" If you have not directly shipped any of the products in the table above, you do not need to distribute\nthe enclosed UMDC to your customers.\n\" If you have directly shipped any of the products in the table above, please distribute the enclosed\nUMDC 16-157 to those customers.\n\" Complete the attached fax form (7185-00-1016) and fax it to 1-844-294-7181.\nQuestions \nPlease contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have\nquestions about the information contained in this distributor letter or the enclosed UMDC 16-157.", "product_quantity": "4976", "distribution_pattern": "Nationwide.", "openfda": { "k_number": [ "K880698", "K830935", "K091400", "K121492", "K790583", "K053411", "K070452", "K110188", "K140829", "K071466", "K936204", "K860572", "K000885", "K071132", "K183230", "K140801", "K852111", "K810638", "K111128", "K801289", "K811567", "K935613", "K122472", "K934070", "K781851", "K822867", "K963844", "K012410", "K801561", "K852986", "K974491", "K884184", "K000887", "K921676", "K080618", "K792086", "K021897", "K040872", "K100304", 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"K990899", "K912748", "K051200", "K992921", "K133344", "K192369", "K063400", "K090699", "K891235", "K861697", "K072714", "K003120", "K832775", "K163633", "K911625", "K022661", "K121366", "K952337", "K955087", "K790046", "K920449", "K933287", "K173127", "K141944", "K161533", "K120497", "K895661", "K031043", "K791103", "K862371", "K931183", "K802432", "K800794", "K102914", "K221326", "K920820", "K171650", "K993131", "K831837", "K992085", "K214117", "K801422", "K902455", "K060001", "K810958", "K940143", "K063643", "K972265", "K133803", "K820279", "K180509", "K170147", "K800857", "K905513", "K821360", "K893453", "K926469", "K873428", "K162281", "K854010", "K082275", "K100547", "K791428", "K780573", "K936285", "K791135", "K905709", "K023763", "K030553", "K140827", "K881863", "K994045", "K063306", "K023654", "K811000", "K990992", "K962597", "K880673", "K113437", "K991246", "K823869", "K940971", "K102045", "K052464", "K802233", "K946274", "K920198", "K231465", "K896582", "K904027", "K920397", "K090413", "K063209", "K050574", "K991483", "K980888", "K033847", "K925204", "K896830", "K993590", "K893224", "K971919", "K942009", "K842689", "K802721", "K072686", "K901414", "K062658", "K851636", "K896335", "K973696", "K130990", "K973365", "K802832", "K051321", "K081895", "K921305", "K141750", "K073309" ], "registration_number": [ "3002637618", "1220972", "3043654757", "9611444", "3011061417", "3003795116", "3003460426", "1832216", "1832816", "1827821", "9613069", "3017548799", "1000487132", "9610633", "9610529", "3015525148", "3003539867", "3023949424", "3005529799", "3002809144", "3014607865", "3016438761", "2027969", "3004111573", "8023024", "2432235", "3035708936", "3008178161", "1717966", "3009448641", "3010825766", "3032069621", "2050012", "3023162659", "1219029", "3005146313", "2032900", "9610126", "2050010", "3013660430", "2084025", "1181121", "2247288", "8031673", "3005333358", "8020316", "3004145393", "3003917514", "3007662974", "9680746", "3004493545", "3012526002", "8023060", "1616487", "2085064", "3004529019", "3006421415", "2517506", "1931251", "1423455", "3003422726", "3006198300", "3043149833", "2915274", "2030861", "8043889" ], "fei_number": [ "3002637618", "1220972", "3043654757", "3011061417", "6387", "3003795116", "3003460426", "1832216", "1832816", "3002698769", "3006769061", "1827821", "3017548799", "1000122044", "1000487132", "3023949424", "2967", "3000206414", "3005529799", "3002809144", "3002806809", "3014607865", "3016438761", "3004111573", "2432235", "3003992026", "3035708936", "3008178161", "1717966", "3009448641", "3002807423", "3010825766", "3032069621", "2050012", "3023162659", "1219029", "3005146313", "3003045237", "2050010", "1000206808", "3013660430", "2084025", "1181121", "3003206796", "3005333358", "1000125596", "3004145393", "3002806560", "3003917514", "3007662974", "3000215862", "3004493545", "3002806693", "3012526002", "1616487", "3004529019", "3006421415", "2517506", "1931251", "3003422726", "3006198300", "3043149833", "2915274", "3002806559", "3004445302", "1000135102" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2" } } ] }