{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "155029", "product_res_number": "Z-2157-2017", "event_date_initiated": "2017-04-24", "event_date_created": "2017-05-24", "recall_status": "Terminated", "event_date_terminated": "2018-05-22", "res_event_number": "77145", "product_code": "GKZ", "k_numbers": [ "K081930", "K120771", "K140911" ], "product_description": "UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.", "code_info": "all software versions", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "reason_for_recall": "There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.", "root_cause_description": "Device Design", "action": "An Urgent Medical Device Recall letter dated 4/24/17 was sent to customers to inform them that there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. The letter informs the customers of the issue, impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at Http://www.beckmancoulter.com/customersupport/support, 800-526-7694 in the US and Canada, customers outside the U.S. and Canada are instructed to contact their local Beckman Coulter representative.", "product_quantity": "4880 units total (2119 units in US)", "distribution_pattern": "Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.", "openfda": { "k_number": [ "K992875", "K925274", "K770701", "K160429", "K162414", "K032000", "K081890", "K926124", "K081213", "K222148", "K943967", "K250943", "K071562", "K800533", "K953643", "K920544", "K022161", "K982231", "K855116", "K904253", "K953116", "K874147", "K770550", "K022668", "K260781", "K855117", "K883177", "K904390", "K911385", "K922704", "K951100", "K932030", "K914014", "K964618", "K944128", "K950919", "K944253", "K083420", "K052905", "K022528", "K190294", "K891276", "K990172", "K061150", "K950626", "K925344", "K041882", "K925528", "K882557", "K852371", "K922085", "K974360", "K914744", "K210346", "K850354", "K090346", "K964856", "K790816", "K971110", "K043215", "K982802", "K960072", "K061667", "K901186", "K050436", "K071967", "K910473", "K953598", "K930913", "K153538", "K983562", 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