Tosoh Bioscience Inc: 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 002520

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.

Details from the source

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. Distribution: Global Distribution. US Nationwide. Quantity: 310 units Lot/code info: UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408

UPC codes

14560189210032

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.