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Tosoh Bioscience
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Tosoh Bioscience and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-22FDA-DeviceClass IITosoh testosterone test recalled for inaccurate results
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.
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