Tosoh Bioscience recalls

Recall found. Tosoh Bioscience is named in FDA Class II recall Z-2746-2026 covering ST AIA-Pack Testosterone. Hazard: 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. Identifying details: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408. Status: Ongoing.