Tosoh Bioscience ST AIA-Pack Testosterone test recalled for inaccurate results
What this means
Tosoh Bioscience recalled certain lots of its ST AIA-Pack Testosterone test due to a quality control issue that can produce falsely high or falsely low testosterone measurements. Inaccurate results may lead to unnecessary follow-up testing or delayed diagnosis.
- If you operate a medical laboratory using this device, check if you have affected lot numbers FX12404, FY12407, FY12406, or FZ12408.
- Contact Tosoh Bioscience for instructions on affected test cups and replacement options.
- Do not use affected lots for new patient testing.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2026Want us to check the next one for you?
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