{ "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": "176361", "product_res_number": "Z-0282-2020", "event_date_initiated": "2019-08-09", "event_date_created": "2019-11-04", "recall_status": "Terminated", "event_date_terminated": "2021-01-08", "res_event_number": "83791", "product_code": "DHR", "k_numbers": [ "K972220" ], "product_description": "Rheumatoid Factor Standard (RF CAL)\nCatalogue Number: RF2301\nGTIN: 05055273205039 \nProduct Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.", "code_info": "Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF", "firm_fei_number": "1000361607", "recalling_firm": "Randox Laboratories Ltd.", "address_1": "55 Diamond Road", "city": "Crumlin", "state": "North", "country": "Ireland", "reason_for_recall": "The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.", "root_cause_description": "Nonconforming Material/Component", "action": "1. Review your reagent inventory and replace the value sheet with the new values provided.\n2. Review results generated with the affected batches in line with the clinical profile of the patient.\n3. Discuss the contents of this notice with your Medical Director.\n4. Complete and return the response form 12187-QA to teclhnical.services@randox.com within five working days.", "product_quantity": "17 kits", "distribution_pattern": "US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.", "openfda": { "k_number": [ "K760043", "K923771", "K873064", "K990035", "K915320", "K834391", "K812882", "K853054", "K920124", "K143736", "K840005", "K920753", "K971602", "K922725", "K813309", "K880164", "K791507", "K983084", "K910539", "K904105", "K954892", "K083080", "K850373", "K892445", "K830611", "K810404", "K871196", "K960703", "K971379", "K850296", "K963048", "K942908", "K924036", "K810141", "K874151", "K941398", "K841146", "K792061", "K810221", "K953520", "K960987", "K991467", "K964415", "K811375", "K822905", "K883355", "K863238", "K802688", "K892444", "K792697", "K962836", "K102673", "K032535", "K902462", "K810306", "K041891", "K831941", "K771552", "K771410", "K821941", "K932437", "K955086", "K991409", "K002609", "K854222", "K961169", "K972220", "K830832", "K821319", "K192727", "K855221", "K851099", "K983418", "K962729", "K831597", "K884180", "K060201", "K854820", "K840049", "K162263", "K840863", "K962050", "K993843", "K873782", "K971788", "K923578", "K961545", "K904498", "K961277", "K920220", "K812968", "K071247", "K962015", "K831467", "K843896", "K801961", "K790351", "K993557", "K100499", "K993304", "K933712", "K802448", "K160070", "K000534", "K021394", "K926569", "K024067", "K970373", "K033802", "K983083", "K924056", "K942272", "K883536", "K903852", "K041863", "K182747", "K792695", "K812972", "K771940", "K841454", "K942328", "K990587", "K922151", "K790012", "K851537", "K974370", "K971614", "K894574", "K190088", "K973464", "K981496", "K972456", "K964418", "K984045", "K800268", "K760036", "K883538", "K974889", "K994338", "K020972", "K904310", "K896271", "K871041", "K953261" ], "device_name": "System, Test, Rheumatoid Factor", "medical_specialty_description": "Immunology", "regulation_number": "866.5775", "device_class": "2", "registration_number": [ "3003795116", "3017505309", "1832216", "1827821", "1319808", "9610529", "2245285", "2029372", "3007208259", "3002809144", "3016438761", "2432235", "1421346", "1641328", "3005360469", "3012348571", "3005094123", "9614373", "2250030", "3012471076", "2016706", "2050012", "3005146313", "1318354", "9610126", "1181055", "9610566", "3012963943", "3022178699", "2084025", "2050010", "1181121", "9610806", "3011989923", "1319681", "2026994", "9610746", "1649661", "3002642396", "8043792", "3000308930", "2250051", "3002800697", "3005333358", "3003871639", "2020726", "3010127294", "9680746", "3004493545", "2032682", "1000403749", "1616487", "3015376545", "3004973408", "3000148879", "3006198300", "2242436" ], "fei_number": [ "3002806557", "3001451797", "3003795116", "3017505309", "1832216", "1827821", "3002808340", "1000305841", "2245285", "3007208259", "3002809144", "3016438761", "3002807876", "2432235", "3002808269", "1421346", "1641328", "3012348571", "2250030", "3005094123", "3012471076", "2016706", "2050012", "3005146313", "1318354", "3022178699", "1000206808", "1181055", "3012963943", "2050010", "2084025", "1181121", "3011989923", "2026994", "3003952975", "3002642396", "3000308930", "2250051", "3002800697", "2020726", "3005333358", "3003871639", "3002806560", "3010127294", "3004493545", "3005670738", "1000403749", "1616487", "1000136573", "3015376545", "3004973408", "3000148879", "3001644026", "3006198300", "2242436", "3002806559", "1000306617" ] } } ] }