{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103915", "product_res_number": "Z-0024-2012", "event_date_initiated": "2011-09-12", "event_date_posted": "2011-10-07", "recall_status": "Terminated", "event_date_terminated": "2012-05-11", "res_event_number": "59868", "product_code": "LCP", "k_numbers": [ "K991127" ], "product_description": "VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States.\nContents: \n1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer\n2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer \n3. Wash/Diluent solution, 2 x 1800 mL deionized water\n4. Analytical cartridge, 1 cation exchange cartridge\n5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative\n6. 1 CD Rom - CD R with program parameters\n7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap\n8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative;\n9. Instruction Manual\nBio-Rad Laboratories, Hercules, CA 94547.\n\nPercentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)", "code_info": "Model number: 270-2154; Lot number 70210674, expiry 1/13/13. lot number 70210954, expiry 2/28/13. Both contain Buffer lot numbers AA10685/AA10686, expiry 3/31/13. Model number : 270-0002; Lot number 70010957, expiry 2/28/13. Contains Buffer lot numbers AA10685/AA10686, expiry 3/31/13.", "firm_fei_number": "2915274", "recalling_firm": "Bio-Rad Laboratories, Inc.", "address_1": "4000 Alfred Nobel Drive", "city": "Hercules", "state": "CA", "postal_code": "94547-1803", "additional_info_contact": "Jackie Buckley\n510-741-5309", "reason_for_recall": "A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.", "root_cause_description": "Process control", "action": "Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product.\nCustomers were asked to please translate (if necessary) the attached \"Customer Medical Device Correction Response Form,\" customers should add their local contact information and distribute to all affected customers in their region by mail or fax.\nCompile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter.\nComplete the \"SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM\" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD.\nCustomers would be issued credits for the affected products based on their request. \nFor questions call (510) 741-3954.", "product_quantity": "491 lot 70210674; 298 lot 70210954; 136 lot 70010957", "distribution_pattern": "Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.", "openfda": { "k_number": [ "K041635", "K896582", "K993131", "K801422", "K851636", "K033674", "K893224", "K896334", "K790046", "K792086", "K231465", "K160762", "K072686", "K791428", "K142789", "K896335", "K102914", "K882051", "K042193", "K810714", "K942009", "K810638", "K991483", "K912748", "K080618", "K893453", "K140829", "K120497", "K020235", "K983726", "K861697", "K023654", "K110188", "K031042", "K010748", "K791103", "K071132", "K140827", "K133344", "K941616", "K171650", "K140801", "K920820", "K162281", "K905513", "K880698", "K864643", "K070819", "K991246", "K130860", "K802233", "K110934", "K921305", "K781948", "K022661", "K875354", "K063400", "K802721", "K933287", "K831478", "K801561", "K780573", "K091400", "K063306", "K980888", "K802832", "K913614", "K822867", "K121842", "K192987", "K800857", "K071466", "K051200", "K031296", "K141944", "K961674", "K925204", 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"K021897", "K031380", "K936204", "K031539", "K802432", "K042459", "K902457", "K001392", "K820279", "K832087", "K011933", "K020234", "K952337", "K992085", "K992921", "K904027", "K003120", "K090699", "K895661", "K821360", "K780819", "K994045", "K122472", "K973696", "K904814", "K871679", "K862371", "K880673", "K984268", "K881863", "K800794", "K920397", "K833356", "K102510", "K873428", "K902455", "K962597", "K935613", "K221326", "K013465", "K974491", "K170623", "K810958", "K920198", "K991850", "K990899", "K070734", "K090413", "K033847", "K110313", "K051321", "K151809", "K102045", "K834294", "K791135", "K112015", "K905709", "K931183", "K181915", "K021484", "K113437", "K781851", "K884315", "K993590", "K040872", "K081269", "K052464", "K063643", "K073309", "K011852", "K830935", "K874749", "K871388", "K984529", "K100547", "K060650", "K990992", "K041764", "K091711", "K030553", "K930823" ], "registration_number": [ "2050012", "1220972", "3043149833", "3004493545", "2032900", "1616487", "1000487132", "3012526002", "3043654757", "3035708936", "3013660430", "3004111573", "9680746", "2915274", "3003917514", "3002809144", "3023949424", "2084025", "2050010", "1219029", "1931251", "3004529019", "1832816", "3016438761", "3009448641", "9610633", "9610126", "8031673", "8023024", "2027969", "8043889", "3005146313", "1717966", "1827821", "2517506", "3032069621", "3023162659", "3003422726", "8020316", "3003795116", "3011061417", "3014607865", "3008178161", "3015525148", "2030861", "3004145393", "3005333358", "9611444", "3010825766", "3003460426", "3002637618", "1423455", "3006421415", "2432235", "2247288", "1181121", "3007662974", "3017548799", "2085064", "3006198300", "9613069", "8023060", "3003539867", "9610529", "3005529799", "1832216" ], "fei_number": [ "2050012", "1000135102", "1220972", "3043149833", "3000206414", "3004493545", "1616487", "1000487132", "3012526002", "3043654757", "3003992026", "3035708936", "3013660430", "3004111573", "2915274", "3002807423", "3003917514", "3002809144", "3023949424", "2084025", "2050010", "1219029", "3003045237", "3002806560", "1931251", "3004529019", "1832816", "3016438761", "3009448641", "3002698769", "3002806809", "2967", "3002806693", "3005146313", "1717966", "1827821", "3002806559", "3032069621", "2517506", "3023162659", "3003422726", "3004445302", "3003795116", "3011061417", "3006769061", "3014607865", "3008178161", "3000215862", "3004145393", "6387", "3003206796", "1000206808", "3005333358", "3003460426", "3010825766", "3002637618", "3006421415", "2432235", "1181121", "3007662974", "3017548799", "1000125596", "3006198300", "3005529799", "1832216", "1000122044" ], "device_name": "Assay, Glycosylated Hemoglobin", "medical_specialty_description": "Hematology", "regulation_number": "864.7470", "device_class": "2" } } ] }