{"recall":{"id":"fda-device-99210","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone","firm":"Tosoh Bioscience Inc","date":"2026-06-12","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"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":"UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408","quantity":"310 units","number":"Z-2746-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Global Distribution. US Nationwide.","nationwide":true,"states":[],"units":"310 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99210","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9f1c9a168bb6bae1","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99210","record":[{"status":"Ongoing","city":"Grove City","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99210","recalling_firm":"Tosoh Bioscience Inc","address_1":"3600 Gantz Rd","address_2":"","postal_code":"43123-1895","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Global Distribution. US Nationwide.","recall_number":"Z-2746-2026","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","product_quantity":"310 units","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.","recall_initiation_date":"20260612","center_classification_date":"20260716","report_date":"20260722","code_info":"UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408","more_code_info":""}]}}