ST AIA-Pack Testosterone — Class II medical device recall Z-2746-2026
Ongoing recall by Tosoh Bioscience Inc, reported 2026-07-22, distributed nationwide. The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the A
| Recall number | Z-2746-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2026-06-12 |
| Classified | 2026-07-16 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 310 units |
| UPC / GTIN / UDI-DI | 14560189210032 |
| Lot numbers | FX12404, FY12406, FY12407, FZ12408 |
| Model numbers | 0025204 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2746-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.