FDA Medical devices recall ·
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the… recall
- Recall number
- Z-2746-2026
- Date
- (initiated June 12, 2026)
- Company / brand
- Tosoh Bioscience Inc
3600 Gantz Rd, Grove City, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 310 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Distribution
Global Distribution. US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2746-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.