ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
Tosoh Bioscience Inc · 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 c…
- Status
- Ongoing
- City
- Grove City
- State
- OH
- Country
- United States
- Classification
- Class II
- Product type
- Devices
- Event ID
- 99210
- Recalling firm
- Tosoh Bioscience Inc
- Address 1
- 3600 Gantz Rd
- Postal code
- 43123-1895
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Global Distribution. US Nationwide.
- Recall number
- Z-2746-2026
- Product quantity
- 310 units
- Recall initiation date
- 20260612
- Center classification date
- 20260716
- Report date
- 20260722
- Code info
- UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
- 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.