{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "222797", "product_res_number": "Z-0201-2027", "event_date_initiated": "2026-09-21", "event_date_posted": "2026-10-21", "recall_status": "Open, Classified", "res_event_number": "99882", "product_code": "JQC", "product_description": "ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471)", "code_info": "Serial Numbers: 24U15260 to 26U15764;\nOptima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860", "firm_fei_number": "3007448124", "recalling_firm": "Beckman Coulter, Inc.", "address_1": "5355 W 76th St", "city": "Indianapolis", "state": "IN", "postal_code": "46268-4166", "additional_info_contact": "Kristin Godfredsen\n760-419-7078", "reason_for_recall": "Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to biohazardous materials.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/26 was sent to customers.\n\nReturn the completed customer response form to Beckman Coulter. Upon receipt of your form, we will coordinate a replacement of your rotor(s).\nIf you have another compatible rotor available that is not included in the Serial Numbers listed above, discontinue use of the affected rotor(s) and use the alternative rotor until your replacement rotor is received. A description of the compatible rotors is available in the instrument instructions for use.\nIf no alternative compatible rotor is available and continued use is necessary, you may continue to use your current rotor until you receive a replacement rotor; however, continued use carries a possibility of rotor breakage which may result in significant damage to materials (i.e., samples) being run in the centrifuge and the centrifuge instrument.\nShould you experience rotor breakage, please contact your service representative. Use personal protective equipment, and standard laboratory operating procedures for the handling of biohazardous materials when opening the centrifuge to prevent exposure to damaged materials (i.e., samples).\nOnce your completed response form is received, a Beckman Coulter representative will coordinate a free-of-charge replacement order for you.\nPlease share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.\nSo that we are assured you have received this important communication, please respond within 10 days in one of the following ways:\n\" Electronically, if you received this communication via electronic system.\n\" Manually, complete and return the enclosed Response Form.\nIf you have any questions regarding this notice, please contact Customer Support Center.\n\"From our website: http://www.beckman.com\n\"By", "product_quantity": "92 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K860747", "K042473", "K103340", "K831948", "K070666", "K843088", "K183205", "K840768", "K822422", "K944738", "K994148", "K052925", "K881254", "K831942", "K991430", "K782124", "K071934", "K030555", "K831947", "K024080", "K800381", "K850485", "K821756", "K822715", "K812505", "K843087", "K761013", "K864974", "K021902", "K081345", "K802210", "K760467", "K843434", "K813524", "K810833", "K860172", "K030340", "K861146" ], "device_name": "Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2050", "device_class": "1", "registration_number": [ "3043009938", "3010402964", "3010381606", "3013894805", "3020704423", "3004111573", "3007193505", "3005273623", "3013530901", "8010471", "1450662", "3012329552", "1721676", "3017450368", "3007712511", "3005743849", "3027339877", "3004488394", "3006788678", "3013846070", "3012101664", "3014657561", "9613959", "3027645317", "3015806723", "3012818475", "3012315023", "1643817", "3031184338", "3007123908", "3012481754", "3010082909", "3010188766", "2084346", "3015539532", "8010672", "1220246", "3003559191", "3016758972", "1067123", "2032098", "3021336182", "3004142400", "3002821232", "3004578971", "3004140833", "3005332796", "1836161", "8010707", "2249760", "3008496303", "9680602", "3008132398", "3009711478", "3017036472", "1061124", "3009302820", "3014326253", "3013767421", "3010408396", "9615162", "9617475", "3010400367", "3009756153", "3003755939", "3009746061", "2244900", "3043138885", "3032542289", "9680411", "3014004349", "3033273466", "3008412416", "3021226419", "1066491", "1423537", "3017791237", "3003799895", "3010420046", "3042989733", "3015086789", "3029995182", "3002579136", "1000122786", "3021013124", "3006404071", "3006697110", "3019916040", "3011544811", "9611274", "3019269298", "3028019212", "3012942167", "9617426", "3021639773", "3027555954", "3005990076", "3009423112", "3017155466", "3016851379", "3010704506", "3010394461", "3008773490", "3030178466", "3006897996", "9616088", "3031700059", "3010386080", "3010392991", "3010455511", "1061932", "3014060475", "3012187635", "1825034", "3011765035", "3048141116", "3014325803", "3016919945", "3030040496", "2050012", "3003402518", "2242368", "1423662", "1417592", "3010331645", "3009155756", "3004548776", "3008496560", "3013756523", "3005778453", "3015651306", "2025606", "3011966385", "3013576619", "3009963993", "3015231789", "3004417597", "3019387954", "3015974593", "3013510285", "1066733", "3007448124", "3003965134", "3011260354", "3030516433", "3004198394", "3009034535", "2032521", "3010031137", "3009407607", "8030607", "1616487", "3033848228", "3005271071", "3007895168", "3015505238", "3043088937", "3045058049", "3011230048", "1220477", "3011816315", "3003510542", "3012821221", "3010047203", "3012494290", "3017056269" ], "fei_number": [ "3043009938", "3008237786", "3010402964", "3010381606", "3013894805", "3020704423", "3004111573", "3007193505", "3005273623", "3002807091", "3013530901", "1450662", "3012329552", "1721676", "3017450368", "3007712511", "3002808043", "3005743849", "3027339877", "3004488394", "3006788678", "3013846070", "3012101664", "3014657561", "7298", "3027645317", "3015806723", "3012818475", "3012315023", "1000124817", "1643817", "3031184338", "3007123908", 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