{ "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": "131698", "product_res_number": "Z-0856-2015", "event_date_initiated": "2014-11-19", "event_date_posted": "2014-12-23", "recall_status": "Terminated", "event_date_terminated": "2015-06-22", "res_event_number": "69847", "product_code": "OUG", "product_description": "Lite DM (Lite Data Manager)\nSoftware Version(s): Versions 2.0.0.19 and lower\nProduct Model #: D00A00224D\n\nThe Lite DM (Lite Data Manager) is a software application developed by HORIBA\nMedical intended to receive, store, and manage Startup, Patient, and Quality Control\n(QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200\nHematology Analyzer. Only one instrument connection is allowed per each Lite DM\nworkstation. The Lite DM application runs on a PC within a Windows Operating\nSystem platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS Laboratory Information System or EMR Electronic Medical Record system).\n\nFollowing the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.", "code_info": "Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A", "firm_fei_number": "3002698356", "recalling_firm": "Horiba Instruments Inc", "address_1": "9755 Research Dr", "city": "Irvine", "state": "CA", "postal_code": "92618-4626", "additional_info_contact": "949-453-0500", "reason_for_recall": "HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19\n\nIMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is", "root_cause_description": "Software change control", "action": "ACTION/RESOLUTION:\nBefore accepting any results please verify the Sample ID in the Worklist matches the Sample ID of the Patient information displayed for the results (Figure 1 below). If the two numbers do not match please contact HORIBA Medical Technical Support.\n\nYour Lite DM should be upgraded to V3.0.0.21. Please contact HORIBA Medical Technical Support to schedule an upgrade. Please call the following phone # 1(888) 903-5001 prompt # 3.\n\nPlease share this information with your laboratory staff and retain this notification as part of your laboratory documentation. It is mandatory for you to complete and return the enclosed response form within 10 days, in order for us to verify your\nunderstanding of this Field Information Notice.\n\nIf you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory.", "product_quantity": "322 (5 in U.S. Military)", "distribution_pattern": "Nationwide within the U.S.", "openfda": { "k_number": [ "K122361" ], "device_name": "Medical Device Data System", "medical_specialty_description": "General Hospital", "regulation_number": "880.6310", "device_class": "1", "registration_number": [ "", "3012164459", "3002725312", "3044827674", "3004548776", "3006990600", "1320150", "8030931", "2182208", "3003616071", "9680625", "2124215", "3014945378", "3013922904", "3010342382", "3031158", "1422681", "3015328411", "3011353843", "3019545235", "3003630693", "3043041722", "3016053964", "3026585241", "3042243260", "1643264", "9610816", "3019269298", "3004123209", "9615754", "3015134086", "1219343", "3027502949", "9611102", "3002579136", "3027204138", "1218950", "1926681", "3009555440", "3004091615", "8030229", "3004167969", "3007923088", "2084725", "3011683100", "3007699086", "3017415521", 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