{ "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": "167743", "product_res_number": "Z-0600-2019", "event_date_initiated": "2018-09-28", "event_date_created": "2018-12-13", "recall_status": "Terminated", "event_date_terminated": "2020-09-03", "res_event_number": "81190", "product_code": "KHO", "product_description": "AIA-900Analyzer, Product code 022930, 022930R\n\nThe AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.", "code_info": "Affects all active analyzers. 022930, 022930R", "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": "Ms. Bernadette O'Connell\n800-248-6764", "reason_for_recall": "Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.", "root_cause_description": "Process control", "action": "On September 28, 2018, the firm, Tosoh Bioscience, notified consignees via an \"URGENT: MEDICAL DEVICE RECALL\" letter. The letter described the product, problem and actions to be taken. The letter informed customers that the AIA-900 and AIA -2000 analyzers had a potential issue that could result in slippage of the incubator unit within the system.\n\nImmediate Actions to be taken by the Customer/User\n\" Thoroughly review the content of this letter.\n\" Continue to use your Instrument.\no Contact Tosoh Technical Support if mechanical errors occur.\no The tension of the timing belt will be assessed and adjusted as needed at the next scheduled preventive maintenance visit.\n\" Complete and return the attached Acknowledgement Form via Fax to: 1-605-636-8651; email: biorecallresponse@tosoh.com or mail to: Recall Coordinator, Tosoh Bioscience, Inc., 3600 Gantz Road, Grove City, OH 43123.\n\" File this notice with your laboratory records and forward this information to others in your laboratory.\nIf you have obtained unexpected test results, delays in test result reporting, or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.\n\nShould you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com Monday - Friday, from 9:00 AM to 5:00 PM (PST).", "product_quantity": "395", "distribution_pattern": "US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.", "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" } } ] }