{ "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": "167650", "product_res_number": "Z-0602-2019", "event_date_initiated": "2017-09-28", "event_date_created": "2018-12-13", "recall_status": "Terminated", "event_date_terminated": "2020-12-08", "res_event_number": "81172", "product_code": "KHO", "product_description": "AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.", "code_info": "All active analyzer serial numbers", "firm_fei_number": "3005529799", "recalling_firm": "Tosoh Bioscience Inc", "address_1": "3600 Gantz Rd", "city": "Grove City", "state": "OH", "postal_code": "43123-1895", "additional_info_contact": "Bernadette O'Connell\n800-248-6764", "reason_for_recall": "The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . \n\nIf observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. \n\nIf the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.", "root_cause_description": "Component design/selection", "action": "On September 28, 2018, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed of the potential issue.\n\nImmediate Actions to be taken by the Customer:\n\nThoroughly review the content of this letter.\n\" Identify if the serial number of your analyzer is listed in this notification.\no If the serial number of your analyzer is listed:\n1. At the next service call or scheduled PM, whichever occurs first, a Tosoh field service\nengineer will verify the motor drive harness and mixing home detection sensor relay\nharness are bundled together and placed into a double-coated cable or repair the\nharness bundle as applicable.\n2. Complete and return the attached Acknowledgement Form by any of the listed\nmethods.\no If the serial number of your analyzer is not listed:\n1. Tosoh records indicate that the harness bundle on your instrument(s) has already\nbeen replaced. Complete and return the attached Acknowledgement Form by any of\nthe listed methods.\n\" File this notice with your laboratory records and forward this information to other supervisors or\nmanagers in your laboratory to ensure that they are aware of the potential issue.", "product_quantity": "258", "distribution_pattern": "Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.", "openfda": { "k_number": [ "K823112", "K971103", "K790235", "K901674", "K760261", "K973547", "K930689", "K791329", "K780122", "K780242", "K822772", "K112161", "K872803", "K894159", "K860309", "K950415", "K920888", "K926131", "K923021", "K830624", "K895240", "K822942", "K913130", "K851984", "K780031", "K962919", "K822701", "K780362", "K890908", "K813540", "K811019", "K760506", "K802579", "K813146", "K935047", "K790236", "K871550", "K952719" ], "registration_number": [ "3007113174", "3038371335", "8031673", "3007349751", "3016733849", "3014150341", "2024800", "3034246205", "3005529799", "3003559191", "3002642396", "3013960814", "3005273623", "3010031137", "3006198300", "3033751096", "3004205692", "3003366417", "3002637618", "3033507883", "2024674", "3021090658", "3012516456", "2250051", "3003542872", "3013223546", "3009092698", "3009491259", "3007606081", "3010082909", "3002792284", "2022994", "2517506", "3004529019", "3029906631", "3002710220", "3017356406", "3010324880", "3000308930", "3005174594", "1319681", "8043909", "3010381606", "3012963943", "3042250641", "2030861", "3014397113", "3029916095", "3005345870", "3016245321", "3013982035" ], "fei_number": [ "3007113174", "3038371335", "3007349751", "3016733849", "3014150341", "2024800", "3034246205", "3005529799", "3003559191", "3002642396", "3013960814", "3005273623", "3010031137", "3006198300", "3000215862", "3033751096", "3004205692", "3003366417", "3002637618", "3002808498", "3033507883", "2024674", "3021090658", "3012516456", "2250051", "3003542872", "3013223546", "3009092698", "3009491259", "3007606081", "3010082909", "1000136573", "3002792284", "2022994", "2517506", "3004529019", "3029906631", "3002710220", "3017356406", "3010324880", "3000308930", "3005174594", "2967", "3010381606", "3012963943", "3042250641", "3014397113", "3029916095", "3005345870", "3016245321", "3013982035" ], "device_name": "Fluorometer, For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2560", "device_class": "1" } } ] }