Tosoh ST AIA-Pack Testosterone
Tosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
Contact your laboratory or clinical facility to determine if your testing equipment is affected and follow the manufacturer's instructions for updated quality control procedures.
Recall at a glance
- Quantity recalled
- 310 units
Why it was recalled
Tosoh Bioscience is recalling this in vitro diagnostic test kit due to quality control results that may cause falsely elevated or falsely low total testosterone measurements. These erroneous results could lead to diagnostic delays or incorrect clinical treatment decisions.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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
- Lot code
- FX12404, FY12407, FY12406, FZ12408
- UDI-DI
- 14560189210032
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-07-17 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification