{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150840", "product_res_number": "Z-0768-2017", "event_date_initiated": "2016-10-25", "event_date_posted": "2016-12-15", "recall_status": "Terminated", "event_date_terminated": "2017-05-01", "res_event_number": "75576", "product_code": "OUG", "product_description": "MicroScan LabPro Data Management System.\n\nIntended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.", "code_info": "Software Version 4.42, Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.", "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": "Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using\nLabPro Data Management System version 4.42. The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.", "root_cause_description": "Device Design", "action": "An Urgent Medical Device Recall letter dated 10/25/16 was sent to all their customers to inform them that Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. Customers are informed that the issue could cause WalkAway workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels. The letter informs the customers of the actions to be taken and the resolution for the product on recall. 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 their Customer Support representative: http://www.beckmancoulter.com\nor call 1-800-677-7226, option 1 in the United States.", "product_quantity": "131 units total (130 units in US)", "distribution_pattern": "Worldwide Distribution -- United States and Mexico.", "openfda": { "k_number": [ "K122361" ], "registration_number": [ "", "3016851379", "2919016", "3023709806", "3029300449", "1219343", "3015185344", "3027502949", "3013003882", "3016727307", "3008493238", "3014926240", "3004945409", "3021226419", "3013528571", "3011786259", "3008959444", "3004070020", "3038356864", "9613959", "3014428919", "1218950", "3010258456", "3004091281", "3037966017", "8010273", "3010120339", "3010960914", "2242863", "8010177", "3011521456", "3009189893", "3043041722", "3007832484", "8043629", "3030926959", "3006615210", "3018094310", "3042852637", "3005383085", "3004123209", "3008921101", "3013319212", "3037000637", "3026566521", 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"medical_specialty_description": "General Hospital", "regulation_number": "880.6310", "device_class": "1" } } ] }