Z-2746-2026 Class II Ongoing
FDA device recall Z-2746-2026 was initiated by Tosoh Bioscience Inc on June 12, 2026 and is designated Class II. 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 tota… The recall status is ongoing. Affected quantity: 310 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2026
- Initiation Date
- June 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 310 units
Product Description
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
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.
Distribution Pattern
Global Distribution. US Nationwide.
Code Information
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408