{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "90289", "product_res_number": "Z-0448-2011", "event_date_initiated": "2010-03-04", "event_date_posted": "2010-11-23", "recall_status": "Terminated", "event_date_terminated": "2012-05-07", "res_event_number": "55200", "product_code": "CHP", "k_numbers": [ "K973743" ], "product_description": "Access Immunoassay Systems Estradiol, Part Number: 33540\nIntended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.", "code_info": "Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6208", "reason_for_recall": "The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.", "root_cause_description": "Other", "action": "A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs.\n\nThe following product replacement contacts were provided:\nIn the United States, please contact Client Services at 1-800-526-3821.\nIn Canada, please contact Customer Service at 1-800-463-7828.\nOutside the United States and Canada, contact your local Beckman Coulter Representative.\n\nQuestions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.", "product_quantity": "20,209 units (5475 in US)", "distribution_pattern": "Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia", "openfda": { "k_number": [ "K884105", "K932926", "K882343", "K912318", "K853866", "K791652", "K933066", "K810695", "K890645", "K933464", "K910249", "K932715", "K941168", "K965109", "K902358", "K932084", "K953605", "K920047", "K873550", "K041349", "K896270", "K970386", "K970126", "K911396", "K943193", "K861361", "K862603", "K951360", "K955647", "K853208", "K970643", "K954697", "K810204", "K882173", "K790679", "K896145", "K931740", "K946199", "K870405", "K973901", "K840051", "K912917", "K913162", "K841947", "K851540", "K973743", "K820329", "K800920", "K834586", "K925498" ], "registration_number": [ "", "3007113174", "8010132", "2432235", "9612316", "8031673", "2182595", "3007349751", "2419955", "3017894300", "3022178699", "3005542422", "2245285", "2020726", "3003760091", "3017019647", "3005529799", "3009984016", "3003559191", "3002642396", "3002809144", "1827821", "3007111389", "2133982", "3006198300", "3009518015", "1219913", "3011989923", "2029372", "1036362", "9610126", "2122870", "8021924", "2250051", "3009335633", "3002806944", "9680746", "3009092698", "3009491259", "3003741796", "3004192065", "9710337", "8020790", "1222302", "8020888", "2032682", "3000308930", "3017379203", "3005094123", "1319681", "8023018", "3005333358", "3002800697", "2032839", "3003385757" ], "fei_number": [ "", "3007113174", "3002808328", "3002676602", "2432235", "3017894300", "2419955", "2182595", "3007349751", "3002806559", "3022178699", "2245285", "3005542422", "1000206808", "2020726", "3003760091", "3017019647", "3005529799", "3009984016", "3003559191", "3002642396", "3002809144", "1827821", "3007111389", "1000306617", "3006198300", "3009518015", "3002807272", "1219913", "3011989923", "1036362", "3000717645", "3002485711", "3004185580", "1000121039", "2122870", "2250051", "3009335633", "3002806944", "3003952975", "1000611339", "3009092698", "3009491259", "3003741796", "1000136573", "3004192065", "3002806808", "3000308930", "3017379203", "3005094123", "2967", "3005333358", "3002800697", "3007019572", "3003385757" ], "device_name": "Radioimmunoassay, Estradiol", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1260", "device_class": "1" } } ] }