{ "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": "113586", "product_res_number": "Z-0255-2013", "event_date_initiated": "2012-06-01", "event_date_posted": "2012-11-06", "recall_status": "Terminated", "event_date_terminated": "2016-08-22", "res_event_number": "62580", "product_code": "GKZ", "k_numbers": [ "K071967" ], "product_description": "Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7\n\nThe Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.", "code_info": "catalog #063-7591-7, all serial numbers", "firm_fei_number": "1000515253", "recalling_firm": "Sysmex America, Inc.", "address_1": "1 Nelson C White Pkwy", "city": "Mundelein", "state": "IL", "postal_code": "60060-9528", "additional_info_contact": "888-879-7639", "reason_for_recall": "There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.", "root_cause_description": "Device Design", "action": "Sysmex America, Inc. sent a \"PRODUCT NOTIFICATION\" letter dated May 2012 to all affected customers on June 1, 2012. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to review patient results to determine if their Reference Intervals need adjustment, and to review QC results via Insight and document any change that may be linked to the date of calibration if appropriate. \n\nAny questions concerning the information contained in the notification were directed to the Sysmex Technical Assistance Center at 1-888-879-7639.", "product_quantity": "763 units", "distribution_pattern": "Nationwide distribution: USA including Puerto Rico.", "openfda": { "k_number": [ "K991454", "K053308", "K914014", "K882370", "K980635", "K841852", "K081930", "K791108", "K935720", "K936023", "K884605", "K160429", "K893852", "K923237", "K022161", "K190898", "K873256", "K961623", "K950057", "K053497", "K844645", "K022668", "K032039", "K003796", "K982166", "K211840", "K954594", "K050436", "K925528", "K251249", "K953340", "K040725", "K963263", "K974360", "K002646", "K071141", "K940003", "K925344", "K980614", "K911385", "K962633", "K945692", 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