{ "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": "93597", "product_res_number": "Z-0431-2011", "event_date_initiated": "2010-07-26", "event_date_posted": "2010-11-22", "recall_status": "Terminated", "event_date_terminated": "2012-05-04", "res_event_number": "56416", "product_code": "CDZ", "k_numbers": [ "K083867" ], "product_description": "Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617\nThe Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.", "code_info": "Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628,  917613, 919184", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6208", "additional_info_contact": "Clair K. ODonovan, Ph.D.\n714-961-4483", "reason_for_recall": "The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be used\nwhen calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values and Access Testosterone (ng/mL) values are reported in different default units. The testosterone value (when reported in ng/mL) requires conversion to nmol/L before the FAI % can be calculated.", "root_cause_description": "Pending", "action": "Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter on the week of July 26, 2010 to the affected customers. The letter was dated July 30, 2010, and identified the product, the problem and provided the appropriate equation to recalculate the FAI% values. \n\nThe customers were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. \nCustomers were also asked to complete and return the enclosed response form within 10 days to confirm that they had received the important notification.\n\nThe customers were instructed to contact Beckman Coulter Technical Support at 1-800-854-3633 in the United States, or contact their local Beckman Coulter Representative if they had any questions regarding the notification.", "product_quantity": "1,113 Units ( 894 in US & 219 in Canada)", "distribution_pattern": "Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada", "openfda": { "k_number": [ "K093421", "K905247", "K840187", "K023091", "K860130", "K955102", "K211685", "K964889", "K854674", "K830512", "K803001", "K191350", "K000043", "K101388", "K924257", "K841948", "K002294", "K190121", "K182521", "K802728", "K802135", "K952281", "K853865", "K801666", "K912850", "K915823", "K021972", "K152155", "K813059", "K014120", "K120009", "K963080", "K831342", "K091867", "K143075", "K772191", "K940449", "K904100", "K861679", "K223405", "K811536", "K151986", "K971823", "K841042", "K791999", "K790007", "K854671", "K201908", "K934562", "K932951", "K884809", "K001086", "K041866", "K941797", "K060818", "K780792", "K844423", "K955870", "K083867", "K052649", "K233480", "K122793", "K800776", "K133491", "K181017", "K152185", "K955440", "K102814", "K915164", "K951685", "K031717", "K802661", "K151529", "K862483", "K032881", "K915570", "K983212", "K153577", "K240865", "K800921", "K030730", "K001935", "K883267", "K813401", "K973900", "K021326", "K252728", "K860003", "K191533" ], "registration_number": [ "9615037", "1036362", "1832216", "3033967997", "2032087", "1827821", "2122870", "8010132", "9612316", "3007118747", "3003385757", "2245285", "2029372", "3009092698", "2182595", "3005529799", "3002809144", "1222302", "2432235", "2133982", "9710337", "8021924", "9610126", "3022178699", "8023018", "3012963943", "2018685", "3007349751", "3011989923", "3007111389", "1219913", "8031673", "3010324880", "1319681", "3002642396", "9610746", "3000308930", "2250051", "3002800697", "3003030793", "3005333358", "1415939", "2020726", "2032839", "3003559191", "1063851", "8032314", "2032682", "2517506", "2419955", "3004192065", "3002806944", "3006198300", "3005542422", "3005984081", "8020888", "3007361513" ], "fei_number": [ "3002806557", "3002808140", "1036362", "1832216", "3033967997", "3002485711", "1827821", "3002808328", "2122870", "1000306617", "3007118747", "3003385757", "2967", "2245285", "3002807272", "3009092698", "2182595", "3007019572", "3005529799", "1000442352", "3002809144", "3002806808", "2432235", "3003355251", "3004185580", "3003261083", "3022178699", "2018685", "3012963943", "3007349751", "3011989923", "3007111389", "1219913", "3005984081", "3010324880", "3000717645", "3002642396", "3003952975", "3000308930", "2250051", "3002800697", "3003030793", "3005333358", "1415939", "2020726", "3003559191", "1000121039", "1000136573", "2517506", "2419955", "3004192065", "3002806944", "3006198300", "3005542422", "3002806559", "3002676602", "3007361513" ], "device_name": "Radioimmunoassay, Testosterones And Dihydrotestosterone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1680", "device_class": "1" } } ] }