Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone
- Recalling company
- Tosoh Bioscience Inc
- Product
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 12, 2026
- Reported
- Jul 22, 2026
- Distribution
- Global Distribution. US Nationwide.
- Status
- Ongoing
- Quantity
- 310 units
- Lot / codes
- UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- Company location
- Grove City, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2746-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2746-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.