{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221069", "product_res_number": "Z-2746-2026", "event_date_initiated": "2026-06-12", "event_date_posted": "2026-07-16", "recall_status": "Open, Classified", "res_event_number": "99210", "product_code": "CDZ", "k_numbers": [ "K023091" ], "product_description": "ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204", "code_info": "UDI-DI: 14560189210032;\nLot Numbers: FX12404, FY12407, FY12406, FZ12408", "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": "Isabelle Lang-Zwosta\n615-8064671", "reason_for_recall": "The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.", "root_cause_description": "Component design/selection", "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 6/9/26 was sent to customers.\n\nImmediate Actions to be taken by the Customer\n1. REVIEW your inventory for the affected lots.\n2. COMMUNICATE and review the information in this notification with the Medical Director and/or Lab Director and with others in your laboratory staff as soon as possible.\n3. MAINTAIN this notification with your laboratory records and forward this notification to others in your laboratory staff\n4. SEGREGRATE and quarantine all affected lots upon review of your inventory. Affected product lot should not be used.\n5. COMPLETE and return the attached acknowledgement form to Tosoh Bioscience Inc. within 15 days of receiving this notification whether you have affected lots or not. Instructions for return of your remaining product to Tosoh Bioscience Inc. are stated below.\n\nReturn of Product and Available Assistance:\nCONTACT the Tosoh Customer Service department at 1-866-527-3587 to arrange return of the affected product.\nSince this recall might affect availability of the product on the market, we will only be able to accommodate limited order quantities. Representatives can also answer questions related to replacements.\nFor questions related to this notification and/or acknowledgement form that are not adequately addressed in the letter, please contact by (email) TESrecall@tosoh.com or call Tosoh Technical Support (phone) 1-800-248-6764.\nReplenishment of Product:\nFor replenishment of returned Testosterone test cups, please contact Customer Service department at 1-866-527-3587. Replenishments will be with ST AIA-PACK Testosterone Assay Test Cups from new lots\nAdditional Information:\nIn the event that you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the ST AIA-PACK Testosterone Assay Test Cups and associated Testosterone reagents, please contact\nTosoh Technical Support (phone) 1-800-248-6764 (email) TESrecall@tosoh.com", "product_quantity": "310 units", "distribution_pattern": "Global Distribution. US Nationwide.", "openfda": { "k_number": [ "K181017", "K862483", "K940449", "K791999", "K841042", "K973900", "K934562", "K854674", "K853865", "K983212", "K191533", "K151986", "K860003", "K191350", "K093421", "K083867", "K802661", "K031717", "K952281", "K041866", "K021972", "K021326", "K133491", "K122793", "K240865", "K955870", "K233480", "K971823", "K803001", "K861679", "K101388", "K252728", "K201908", "K152155", "K153577", "K143075", "K182521", "K023091", "K001935", "K813059", "K151529", "K790007", "K091867", "K830512", "K963080", "K941797", "K032881", "K030730", "K002294", "K800776", "K884809", "K951685", "K813401", "K831342", "K955102", "K060818", "K964889", "K001086", "K223405", "K190121", "K840187", "K801666", "K780792", "K000043", "K152185", "K811536", "K052649", "K883267", "K014120", "K955440", "K932951", "K120009", "K915570", "K772191", "K915164", "K860130", "K924257", "K915823", "K844423", "K211685", "K102814", "K802728", "K802135", "K904100", "K905247", "K841948", "K912850", "K800921", "K854671" ], "registration_number": [ "3003385757", "3003559191", "1219913", "1832216", "3002800697", "1319681", "3002809144", "3010324880", "3003030793", "1222302", "2018685", "8023018", "2182595", "3009092698", "3005542422", "1827821", "2432235", "1063851", "3005529799", "2032087", "2032839", "8032314", "3011989923", "2419955", "9610746", "3033967997", "3002642396", "8021924", "8031673", "3022178699", "3007361513", "3000308930", "3012963943", "3005984081", "2122870", "8020888", "2133982", "3002806944", "1036362", "9710337", "2250051", "2020726", "1415939", "2245285", "9610126", "3007111389", "2029372", "3006198300", "3005333358", "9615037", "2517506", "3004192065", "2032682", "8010132", "9612316", "3007349751", "3007118747" ], "fei_number": [ "3007019572", "3002806559", "3003559191", "3003385757", "1219913", "1832216", "3000717645", "3002800697", "3003952975", "3002809144", "3010324880", "3003030793", "3004185580", "2018685", "2182595", "3002806808", "1000442352", "3009092698", "3005542422", "1827821", "3003355251", "2432235", "3005529799", "3011989923", "2419955", "3002485711", "3033967997", "3002642396", "3000308930", "3022178699", "3007361513", "3002676602", "3002806557", "3012963943", "3005984081", "2122870", "3002807272", "3002806944", "1036362", "1000306617", "2250051", "2020726", "1000121039", "1415939", "2245285", "3003261083", "3007111389", "3006198300", "3005333358", "3002808140", "2967", "2517506", "3004192065", "1000136573", "3007349751", "3002808328", "3007118747" ], "device_name": "Radioimmunoassay, Testosterones And Dihydrotestosterone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1680", "device_class": "1" } } ] }