FDA Medical Device · Z-2746-2026

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

Class II · Ongoing

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.

Affected lots / codes — check yours against thisUDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408

Recalling firm: Tosoh Bioscience Inc, Grove City, OH
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 310 units
Distribution: Global Distribution. US Nationwide.
Recall initiated: June 12, 2026
Classified: July 16, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2746-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

Check this brand across all 8 databases →