Tosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
Tosoh Bioscience is recalling ST AIA-Pack Testosterone test kits due to low-quality control results that could produce falsely elevated or falsely low testosterone measurements, potentially leading to unnecessary testing or delayed diagnosis.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a diagnostic device. The source text explicitly states the hazard is theoretical—no illnesses or injuries are reported, and harms are described as potential ("could cause," "may lead to"). Class II with no reported adverse events typically scores 2 per the rubric.
Plain-English summary
Tosoh Bioscience Inc is recalling ST AIA-Pack Testosterone test kits (Model Number 0025204) used for measuring testosterone levels in human serum on Tosoh AIA System analyzers. The affected lot numbers are FX12404, FY12407, FY12406, and FZ12408 (UDI-DI: 14560189210032). A total of 310 units were distributed globally and throughout the United States.
The recall was initiated because test cup lot F level 1 low-quality control results were lower than expected. This condition could cause the analyzer to report falsely elevated or falsely low total testosterone results. Erroneous test results may lead to additional testing or diagnostic procedures. In limited cases, inaccurate results may also lead to a delay in diagnosis or the initiation of unnecessary or incorrect clinical treatment measures.
Healthcare providers and laboratory personnel using these lot numbers should stop using the affected kits and contact Tosoh Bioscience for replacement or further instructions. Any patient test results from the affected lot numbers should be reviewed for accuracy.
The recalled product
- Product
- 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
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- inaccurate-test-result
- mis-calibration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 14560189210032
- Lot Numbers: FX12404
- FY12407
- FY12406
- FZ12408
Distribution
Distributed nationwide across the United States.
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