United StatesST AIA-Pack Testosterone test kits for in vitro quantitative measurement of testosterone on Tosoh AIA System analyzers, Model Number 0025204 (UDI-DI 14560189210032; Lot FX12404, FY12407, FY12406, FZ12408) are affected. The recall was issued because Test cup lot F level 1 low-quality control results were lower than expected on the Automated Immunoassay Analyzer, which could cause falsely elevated or falsely low total testosterone results and may lead to additional testing or, in limited cases, delays in diagnosis or unnecessary or incorrect clinical treatment measures.
What's being recalled
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
Recalling firm: Tosoh Bioscience Inc, Grove City, OH, United States.
How to identify it
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Global Distribution. US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)