{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217608", "product_res_number": "Z-1135-2026", "event_date_initiated": "2025-12-08", "event_date_posted": "2026-01-21", "recall_status": "Open, Classified", "res_event_number": "98094", "product_code": "LBS", "k_numbers": [ "K040471" ], "product_description": "The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product.\n\nIn phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.", "code_info": "REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361.\nAll Lots and Expiration Dates.\nIFU Version BAOSR6X96-10 and prior.", "firm_fei_number": "1000206808", "recalling_firm": "Beckman Coulter Ireland, Inc.", "address_1": "Lismeehan O'Callaghan'S", "city": "Mills", "country": "Ireland", "additional_info_contact": "Marguerita Sweeney\n(0)65 683 1100", "reason_for_recall": "Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).", "root_cause_description": "Device Design", "action": "On 12/8/2025, recall notices were mailed and emailed to customers who were informed of the following:\n\nA clinically significant interference due to triglyceride concentration up to 1500mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).\n\nDiscontinuance or disposal of this product is not necessary. The LDL Cholesterol reagent can be used with the revised Instructions for Use (IFU) that contain the updated triglyceride interference specifications.\n\nShare the content of this letter with your laboratory and/or Medical Director.\n\nRetain this notification as part of your laboratory Quality System documentation.\n\nIf you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter.\n\nComplete and return the response form via email to regaffairsfax@beckman.com\n\nIf you have any questions regarding this notice, please contact our Customer Support Center: http://www.beckmancoulter.com, or 1-800-854-3633 in the United States.", "product_quantity": "34,451", "distribution_pattern": "US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT, OK, NY, AZ, LA, OR, AL, MO, IN, IL, KY, MS, NH, AK, SD, MN, TN, PR, MI, IA, WI, WV, ME, SC, HI, RI, ND, NE, ID, AR, WY, DC, GU, DE, CT.\n\nOUS: Brazil, South Africa, Argentina, Mexico, Canada, Costa Rica, Peru, El Salvador, Ecuador, Panama, Singapore, Ireland, United Kingdom of Great Britain and Northern Ireland, Germany, China, Korea, Republic of", "openfda": { "k_number": [ "K032932", "K062092", "K120609", "K021671", "K874397", "K943279", "K862845", "K111516", "K971190", "K982539", "K894057", "K790281", "K981899", "K100550", "K033610", "K014032", "K014018", "K973988", "K051962", "K861244", "K103747", "K791990", "K053157", "K813192", "K900036", "K041090", "K963213", "K872050", "K971526", "K072395", "K050632", "K111036", "K792183", "K881891", "K895851", "K905296", "K864522", "K971902", "K041928", "K014015", "K801726", "K954778", "K100010", "K040767", "K971162", "K162593", "K080125", "K972041", "K042006", "K970735", "K914511", "K801834", "K981580", "K871461", "K012286", "K840676", "K153435", "K934045", "K072836", "K895139", "K981224", "K790553", "K991665", "K990581", "K071706", "K801133", "K893548", "K042195", "K073497", "K991664", "K840677", "K792319", "K943028", "K843029", "K871265", "K023640", "K132711", "K982341", "K021316", "K013152" ], "registration_number": [ "2432235", "3006198300", "3004192065", "3017379203", "2050012", "2030861", "2517506", "3002642396", "3023197868", "2250051", "3000308930", "3004493545", "3005452690", "1319681", "3012963943", "1319808", "2032900", "3048199746", "9680746", "1220972", "3005146313", "1319809", "8020316", "3011989923", "9610529", "3016438761", "3020978007", "1827821", "2027969", "3006716639", "3015189693", "2050010", "3003795116", "3003593973", "1181055", "2247288", "1423455", "1616487", "2085064", "2939693", "1063851", "3007662974", "3005333358", "8040374", "3021841051", "9610126", "3003539867" ], "fei_number": [ "2432235", "3006198300", "3002806809", "3004192065", "3017379203", "2050012", "2517506", "1000136573", "3004445302", "3002642396", "3023197868", "2250051", "3000308930", "3004493545", "3000206414", "3005452690", "5864", "3006769061", "3012963943", "1000305840", "1000135102", "1000206808", "3048199746", "1220972", "3005146313", "3011989923", "3020978007", "3016438761", "1827821", "1000122044", "3006716639", "3015189693", "3002806559", "3003795116", "3003593973", "1000442352", "2050010", "1181055", "3000215862", "1000305841", "1616487", "2939693", "3007662974", "1000125596", "3002806560", "3005333358", "3021841051" ], "device_name": "Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1475", "device_class": "1" } } ] }