{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64528", "product_res_number": "Z-0312-2008", "event_date_initiated": "2007-04-18", "event_date_posted": "2007-12-22", "recall_status": "Terminated", "event_date_terminated": "2012-04-16", "res_event_number": "44916", "product_code": "GKZ", "k_numbers": [ "K011342" ], "product_description": "COULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer)", "code_info": "Part Number 6605632. All software versions", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92822-6208", "additional_info_contact": "Nora Zerounian\n714-961-3634 Ext. 8383", "reason_for_recall": "Patient Mis-identification can occur:\n1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier.\n2)- When manually entering a Patient ID, if a blank space is entered between th", "root_cause_description": "Software design", "action": "Product Corrective Action (PCA) letters were mailed\non April 18,2007, to all GENS, LH500, LH750 and\nLH780 accounts. They are informed that a potential\nmisidentification can occur in 2 scenarios.\n1. When a positive identifier (Sample ID or\nCassetteIPosition) is manually edited to a\npositive identifier that is already in the ToDo list.\nThe workstation will accept the entry and no\nerror message will be generated, creating 2\nsamples with the identical positive identifier.\n2. When manually entering a Patient ID, if a blank\nspace is entered between the characters in the\nPatient ID field, the system will only accept the\ncharacters before the space.----Short term fix-----\nThe letter explains the issues and provides the\ncustomer work around. (Letters were sent by US\nmail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.", "product_quantity": "2,214 units in US; 130 units in Canada", "distribution_pattern": "World wide: USA and Canada", "openfda": { "k_number": [ "K960072", "K911626", "K160538", "K010765", "K021241", "K992849", "K942525", "K803219", "K091313", "K853304", "K922744", "K953498", "K162977", "K932530", "K030263", "K950918", "K844910", "K941171", "K030144", "K875346", "K945212", "K951459", "K871600", "K933475", "K982167", "K981568", "K961701", "K874147", "K936023", "K833600", "K090346", "K844645", "K945205", "K960887", "K953598", "K950742", "K953340", "K032039", "K060375", "K874427", "K052905", "K963263", "K993356", "K071141", "K922745", "K933486", "K942797", "K953448", "K991839", "K841852", "K943894", "K854242", "K901186", "K043215", "K961439", "K770701", "K880616", "K904253", "K143348", "K171655", "K910834", "K953116", "K883710", "K955504", "K042251", "K000897", "K243283", 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