- Recalling firm
- Tosoh Bioscience Inc
- Reason for recall
- 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 products (lot / model / serial)
- UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- Units affected
- 310 units
- Distribution pattern
- Global Distribution. US Nationwide.
- Firm location
- Grove City, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2746-2026
- Recall initiated
- June 12, 2026
- FDA classification date
- July 16, 2026
- FDA report date
- July 22, 2026
- FDA event ID
- 99210
- Last updated on HTM Vibe
- July 28, 2026